A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy
| Registry | NCT03017235 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: single, other |
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| Enrollment | 917 (Actual) |
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| Sponsor | Ferring Pharmaceuticals (Industry) |
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| Conditions | Bowel Preparation |
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| Interventions | Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution, Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder (Drug) |
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| Dates | start 2017-02-20, primary completion 2017-09-15, completion 2017-10-12, first posted 2017-01-11, last updated 2018-11-14 |
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| Locations | 14 sites in United States, Canada |
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-Summary
The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| NaP/MC Oral Solution | Experimental | Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution | Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution |
| PREPOPIK® | Active comparator | Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder | |
- Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution (Drug): Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
- Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder (Drug), also known as PREPOPIK®, PicoPrep®: Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
+Outcome measures
Primary outcomes
- Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good" [During colonoscopy procedure (5-9 hours after completed treatment)]: The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Secondary outcomes
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon [During colonoscopy procedure (5-9 hours after completed treatment)]: The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.
The BBPS scale:
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon [During colonoscopy procedure (5-9 hours after completed treatment)]: The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.
The BBPS scale:
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon [During colonoscopy procedure (5-9 hours after completed treatment)]: The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.
The BBPS scale:
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) [During colonoscopy procedure (5-9 hours after completed treatment)]: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
- Percentage of Treatment-emergent Adverse Events(AEs) [From baseline (screening) up to day 28 after colonoscopy]: Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.
- Clinically Significant Changes in Vital Signs [From baseline (screening) up to day 28 after colonoscopy]: Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position
- Clinically Significant Changes in Electrocardiogram (ECG) [At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy]: Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.
- Clinically Significant Changes in Laboratory Values [At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy]: Rated by the investigator based on out of range laboratory values
+Eligibility
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria:
* Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
* Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.
* An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy
Exclusion Criteria:
* Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention
* Acute intestinal or gastric ulceration
* Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon
* Undergoing colonoscopy for foreign body removal or decompression
* Reduced level of consciousness or inability to swallow without aspiration
* Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures
* Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)
* Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites
* Severely reduced renal function (<30 mL/min/1.73 m2)
* Pregnant or lactating women
* Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1
* Rhabdomyolysis
* Chronic nausea and vomiting
* Hypermagnesemia
* Undergoing treatment with Lithium
+Posted results
Participant flow
| Milestone | NaP/MC Oral Solution | PREPOPIK® |
|---|
| Started | 456 | 461 |
| Completed | 444 | 447 |
| Not completed | 12 | 14 |
Outcome results
- Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good" (Primary), Number, Percentage of participants: NaP/MC Oral Solution 87.7 (84.3 to 90.6); PREPOPIK® 81.5 (77.6 to 84.9) (p 0.0067)
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon (Secondary), Number, Percentage of subjects: NaP/MC Oral Solution 94.2 (91.6 to 96.2); PREPOPIK® 89.6 (86.4 to 92.3) (p 0.0099)
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon (Secondary), Number, Percentage of subjects: NaP/MC Oral Solution 96.0 (93.7 to 97.6); PREPOPIK® 94.0 (91.4 to 96.0) (p 0.1781)
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon (Secondary), Number, Percentage of subjects: NaP/MC Oral Solution 94.6 (92.1 to 96.5); PREPOPIK® 91.2 (88.2 to 93.6) (p 0.0391)
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 63; PREPOPIK® 47
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 443; PREPOPIK® 448
- Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 400; PREPOPIK® 433
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 11; PREPOPIK® 6
- Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 11; PREPOPIK® 8
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 371; PREPOPIK® 426
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 382; PREPOPIK® 387
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 335; PREPOPIK® 328
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 416; PREPOPIK® 435
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 403; PREPOPIK® 402
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 427; PREPOPIK® 432
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 396; PREPOPIK® 396
- Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 261; PREPOPIK® 281
- Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 56; PREPOPIK® 52
- Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) (Secondary), Count of participants, Participants: NaP/MC Oral Solution 5; PREPOPIK® 5
- Percentage of Treatment-emergent Adverse Events(AEs) (Secondary), Number, Percentage of adverse events: NaP/MC Oral Solution 84.4; PREPOPIK® 84.8
- 3 more outcome measures not shown.
Adverse events
Time frame: From baseline (screening) upto 28 days after colonoscopy.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| NaP/MC Oral Solution | 0/448 (0.0%) | 9/448 (2.0%) | 378/448 (84.4%) |
| PREPOPIK® | 0/453 (0.0%) | 6/453 (1.3%) | 384/453 (84.8%) |
Serious adverse events by term
| Term | Organ system | NaP/MC Oral Solution | PREPOPIK® |
|---|
| Atrial fibrillation | Cardiac disorders | 1/448 | 0/453 |
| Ascites | Gastrointestinal disorders | 1/448 | 0/453 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0/448 | 1/453 |
| Influenza | Infections and infestations | 0/448 | 1/453 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 1/448 | 0/453 |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/448 | 0/453 |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/448 | 1/453 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/448 | 1/453 |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/448 | 0/453 |
| Carcinoid tumour of the gastrointestinal tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/448 | 1/453 |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 0/448 | 1/453 |
Other adverse events by term
| Term | Organ system | NaP/MC Oral Solution | PREPOPIK® |
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| Haemorrhoids | Gastrointestinal disorders | 150/448 | 155/453 |
| Large intestine polyp | Gastrointestinal disorders | 93/448 | 105/453 |
| Diverticulum intestinal | Gastrointestinal disorders | 70/448 | 70/453 |
| Diverticulum | Gastrointestinal disorders | 64/448 | 59/453 |
| Investigations | Infections and infestations | 25/448 | 23/453 |
| Hypermagnesaemia | Metabolism and nutrition disorders | 9/448 | 23/453 |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 133/448 | 128/453 |
| Infections and infestations | Infections and infestations | 27/448 | 35/453 |
| Nervous system disorders | Nervous system disorders | 27/448 | 30/453 |
+Locations (14)
| Facility | City | Country | Status |
|---|
| Clinical Research Associates | Huntsville, Alabama | United States | |
| Associated Gastroenterology Medical Group | Anaheim, California | United States | |
| GW Research, Inc. | Chula Vista, California | United States | |
| Precision Research Institute | San Diego, California | United States | |
| Connecticut Clinical Research Foundation | Bristol, Connecticut | United States | |
| Florida Clinical Research Group | Clearwater, Florida | United States | |
| Nature Coast Clinical Research | Inverness, Florida | United States | |
| Long Island Gastrointestinal Research Group LLC | Great Neck, New York | United States | |
| Kinston Medical Specialists, PA | Kinston, North Carolina | United States | |
| Wake Research Associates, LLC | Raleigh, North Carolina | United States | |
| Hillmont GI | Flourtown, Pennsylvania | United States | |
| Advanced Research Institute | Ogden, Utah | United States | |
| Hotel Dieu Hospital | Kingston | Canada | |
| Canadian Phase Onward, Inc. | Toronto | Canada | |
+Publications
- Results publication: Mankaney GN, Ando M, Dahdal DN, Burke CA. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial. Ther Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021. PMID 34262611
- Results publication: Hookey L, Bertiger G, Johnson KL 2nd, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 10.1177/1756284820910050. eCollection 2020. PMID 32313553
- Results publication: Hookey L, Bertiger G, Johnson KL, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 10.1177/1756284820902878. eCollection 2020. PMID 32095161
- Results publication: Hookey L, Bertiger G, Lee Johnson K 2nd, Ayala J, Seifu Y, Brogadir SP. Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial. Ther Adv Gastroenterol. 2019 May 19;12:1756284819851510. doi: 10.1177/1756284819851510. eCollection 2019. PMID 31205487
+Study documents
+Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals