A Pilot Study to Evaluate Safety and Effectiveness of Lanreotide in the Treatment of Patients With Small Bowel Motility Disorders (SBMD): a Prospective, Non-randomized, Single-center Study of 20 Participants
| Registry | NCT03012594 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | Northwell Health (Other); collaborators: Ipsen |
| Conditions | Gastrointestinal Motility Disorder, Intestinal Disease |
| Interventions | Lanreotide (Drug) |
| Dates | start 2017-05-11, primary completion 2018-10-21, completion 2019-03-11, first posted 2017-01-06, last updated 2021-01-15 |
| Locations | 2 sites in United States |
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This is a human research study looking at the effectiveness of Lanreotide (study medication) in treating small bowel motility disorders. It is similar to a natural hormone somatostatin that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting medication that is given once a month. It is marketed with a trade name "Somatuline Depot". It is given deep subcutaneously (deep within the layers of the skin) in the superior external quadrant of the buttock. Injection site will be alternated on subsequent injections.
The investigators hypothesize that in patients with small bowel motility disorders, Lanreotide helps in alleviating the symptoms. Lanreotide is an FDA approved medication for management of acromegaly and neuroendocrine tumors, but has never been used for treating small bowel motility disorders. However, Octreotide which is similar to Lanreotide but is a short acting synthetic somatostatin has been used in few research studies.
If a patient is interested and qualifies for the study then he/she will be explained about the study and signature will be collected on the consent form. Health and social history will be collected. Blood work, urine analysis, pregnancy test (in women of reproductive age group and have the capability of getting pregnant)) will be performed to make sure that patient qualifies for the study and for follow-up during the treatment. Physical examination, ECG, wireless motility capsule testing and hydrogen breath testing will be performed. Patients will be required to complete a questionnaire regarding their health.
The total study duration from the first administration of study drug is 12 weeks. The study medication will be given once a month for 3 months and there is a 1 month follow-up after the last study medication. There will be a screening visit approximately 1 month before the first study drug administration.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Lanreotide | Experimental | Drug: Lanreotide | Open label |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: 1. Consecutive patients with evidence of small bowel motility disorders, referred to (or) are patients of the Gastroenterology and Motility Center at Northwell Health System. 2. Aged between 18 and 70 years. 3. Subjects should be capable of understanding the study and be able to give informed consent. 4. Patient having small bowel motility disorder as evidenced by delayed small bowel transit by wireless motility capsule (WMC) testing to > 6 hours. 5. To participate in the study, patients will have to stop taking Octreotide (because it has the same mechanism of action as the study medication) if they are currently taking it; it should be stopped for at least 4 weeks before taking the first dose of this study medication. General Exclusion Criteria 1. Age <18 or age >70 2. Pregnancy as assessed by urine pregnancy test. Exclusion Criteria for performing wireless motility capsule testing 1. History of gastric bezoar 2. History of Disorders of swallowing 3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas, Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol abuse) 4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y) 5. History of Severe dysphagia to food or pills 6. A participant who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump 7. Inability to be off intestinal transit altering medication for at least one week (e.g. opiates, laxatives, etc.) 8. Any person unable or unwilling to undergo abdominal surgery. 9. BMI > 40. Exclusion Criteria due to Lanreotide 1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic agents, laxatives, and opiates, or other agents known to affect gastrointestinal motility. 2. Disorders associated with presumed small intestinal motility disorders including: scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g. longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose > 250, glycosylated hemoglobin (HbA1c) > 8.5%) 3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta blockers. 4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain). Bradycardia and Tachycardia are monitored during every visit to the clinic, using pulse rate. ECG will be performed during screening visit and during 8th week of the study. The following are accessed with ECG. * Bradycardia <60 beats/min. * Tachycardia >100 beats/min. * Atrial Fibrillation - Rapid irregular atrial signal with no real P-waves and irregular ventricular rate. * Ventricular Fibrillation - Irregular ventricular waveforms. * Sinus Arrhythmia - Normal beats, but triggered at an irregular interval from 60 to 100 beats per minute, causing varying R-R interval. * Missed beats. 5. Chronic kidney disease (moderate and severe renal impairment as calculated by creatinine clearance of <50 mL/min) 6. Hepatic Impairment - Subjects with Child-Pugh Class B and Class C. 7. Significant electrolyte abnormalities: Anything outside of the normal range by +/- 20 % will be considered as abnormal. 8. Cholelithiasis (Total bilirubin >2x of normal) 9. Pancreatitis 10. Hepatitis (Aspartate transaminase (AST), Alanine transaminase (ALT) or Alkaline phosphatase (Alk Ph), greater than upper limit of normal(ULN), Serum albumin <3.0 g/dL unless prothrombin time is within the normal range) 11. Present cholecystitis 12. Uncontrolled congestive heart failure 13. Known hypersensitivity to the study drug
| Milestone | Lanreotide |
|---|---|
| Started | 12 |
| Completed | 9 |
| Not completed | 3 |
Time frame: 1 month after last dose, up to 4 months from the start for each subject.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Lanreotide | 0/9 (0.0%) | 0/9 (0.0%) | 2/9 (22.2%) |
| Term | Organ system | Lanreotide |
|---|---|---|
| Difficulty swallowing wireless motility capsule pill | Investigations | 1/9 |
| Unable to acknowledge the passage of the wireless motility capsule through the feces | Investigations | 1/9 |
Limitations and caveats: This is a pilot non-randomized study in relatively small number of subjects to identify if Lanreotide will help in alleviating the symptoms and and change gut motility in patients suffering from small bowel motility disorders. A larger study randomized study is required to confirm the findings in this study.
| Facility | City | Country | Status |
|---|---|---|---|
| Long Island Jewish Medical Center | New Hyde Park, New York | United States | |
| Lenox Hill Hospital | New York, New York | United States |