linaclotide: Clinical Trials

44 trials of linaclotide, newest first

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34 completed, 4 unknown, 3 terminated, 2 active not recruiting. 13 Phase 2, 12 Phase 3, 8 Not applicable, 5 Phase 1, 5 Phase 4.

By phase and status

PhaseTrialsStatus
Phase 213Completed 11, Active not recruiting 1, Terminated 1
Phase 312Completed 11, Unknown 1
Not applicable8Completed 4, Unknown 2, Recruiting 1, Terminated 1
Phase 15Completed 5
Phase 45Completed 2, Active not recruiting 1, Terminated 1, Unknown 1

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Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
A Study of Virtual Reality and Linaclotide for IBS-C
Virtual Reality - Irritable Bowel Syndrome With Constipation
Not applicableRecruitingMayo Clinic652024-05-312026-07-29
Clinical Study of Bowel Preparation Before Colonoscopy
OSS, OSS+Linzess, PEG-Interferon Alfa - Bowel Preparation
Not applicableCompletedJinling Hospital, China4442023-08-012024-12-10
A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Linaclotide, Placebo - Functional Constipation
Phase 2CompletedAbbVie192023-04-272026-01-06
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Placebo for Linaclotide, Linaclotide - Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
Phase 3CompletedAbbVie1232022-12-292026-05-14
GCC Agonist Signal in the Small Intestine
Biopsy, Biospecimen Collection, Esophagogastroduodenoscopy - Barrett Esophagus, Gastroesophageal Reflux Disease
Phase 1CompletedUniversity of Wisconsin, Madison432022-11-302026-04-07
Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation
3 L PEG + linaclotide, 3 L PEG + placebo - Colonoscopy
Not applicableCompletedZhiguo Liu7202022-08-012024-05-23
Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy
3L PEG + Linaclotide, 3L PEG, 2L PEG + Linaclotide - Bowel Preparation for Colonoscopy
Not applicableCompletedChanghai Hospital16072022-05-252024-06-20
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
Linaclotide, Compound Polyethylene Glycol Electrolyte Powder - Bowel Preparation
Not applicableUnknownSecond Affiliated Hospital of Xi'an Jiaotong University3002021-09-012021-11-30
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation
Linaclotide, LINZESS®, Placebo - Chronic Idiopathic Constipation
Phase 3UnknownJiangsu Hansoh Pharmaceutical Co., Ltd.7502021-03-052021-03-18
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
Linaclotide, Lactulose, Omeprazol - Functional Dyspepsia, Constipation-predominant Irritable Bowel Syndrome
Phase 4UnknownRenJi Hospital782021-01-012021-12-13
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
Linaclotide, Placebo - Colorectal Adenoma, Stage 0 Colorectal Cancer AJCC v8
Phase 2Active not recruitingSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University1502019-10-302026-10-08
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
Linaclotide, Placebo - Functional Constipation
Phase 2CompletedAllergan352019-10-142022-04-26
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
Linaclotide, Placebo - Functional Constipation, Irritable Bowel Syndrome With Constipation
Phase 3CompletedAbbVie4382019-10-012024-11-26
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Linaclotide, Placebo - Irritable Bowel Syndrome Characterized by Constipation
Phase 3CompletedIronwood Pharmaceuticals, Inc.6142018-06-202020-12-01
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
linaclotide - Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
CompletedAstellas Pharma Inc24752017-10-022024-10-18
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
Linaclotide, Placebo - Irritable Bowel Syndrome Characterized by Constipation
Phase 4TerminatedIronwood Pharmaceuticals, Inc.202016-12-212021-12-06
A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
linaclotide, Placebo - Chronic Constipation
Phase 3CompletedAstellas Pharma Inc1862016-06-242024-10-18
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
Placebo, LIN Dose A, LIN Dose B - Functional Constipation in Children Ages 6-17 Years
Phase 2CompletedForest Laboratories1732015-11-032019-06-19
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
Linaclotide - Irritable Bowel Syndrome With Constipation, Chronic Idiopathic Constipation
Phase 4CompletedForest Laboratories8282015-11-012019-08-22
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
Linaclotide Dose A, Linaclotide Dose B, Linaclotide Dose C - Irritable Bowel Syndrome With Constipation
Phase 2TerminatedForest Laboratories1012015-11-012020-12-28

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Conditions studied

Constipation (8)  ·  Irritable Bowel Syndrome (8)  ·  Colorectal Neoplasms (2)  ·  Barrett Esophagus (1)  ·  Breast Feeding (1)  ·  Colitis, Ulcerative (1)  ·  Diabetes Mellitus (1)  ·  Gastroesophageal Reflux (1)  ·  Gastrointestinal Hemorrhage (1)  ·  Gastrointestinal Neoplasms (1)  ·  Opioid-Induced Constipation (1)

Sponsors

Ironwood Pharmaceuticals, Inc. (11)  ·  Astellas Pharma Inc (7)  ·  Forest Laboratories (6)  ·  AbbVie (3)  ·  Mayo Clinic (2)  ·  Allergan (1)  ·  AstraZeneca (1)  ·  Augusta University (1)  ·  Changhai Hospital (1)  ·  Jiangsu Hansoh Pharmaceutical Co., Ltd. (1)  ·  Jinling Hospital, China (1)  ·  RenJi Hospital (1)  ·  Second Affiliated Hospital of Xi'an Jiaotong University (1)  ·  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University (1)  ·  Texas Tech University Health Sciences Center, El Paso (1)

Countries

United States (29)  ·  China (7)  ·  Japan (7)  ·  Canada (6)  ·  United Kingdom (5)  ·  Bulgaria (3)  ·  Germany (2)  ·  Netherlands (2)  ·  Australia (1)  ·  Belgium (1)  ·  Croatia (1)  ·  Estonia (1)  ·  Hungary (1)  ·  Israel (1)  ·  Italy (1)

Top investigators

Jeffrey M. Johnston, MD, FACP (4)  ·  Anna Muslin (2)  ·  Zhaoshen Li (2)  ·  Adam D Farmer, PhD MRCP (1)  ·  Bernard J Lavins, MD (1)  ·  Brain Lacy, MD, PhD (1)  ·  Chengwei Tang (1)  ·  David S Weinberg (1)  ·  Dongfeng Chen (1)  ·  Dongmei Qian (1)  ·  Huahong Wang (1)  ·  Irene Sarosiek, MD (1)

Results publications

PMID 20045700, PMID 20801122, PMID 21830967, PMID 23116208, PMID 24075889, PMID 25312449, PMID 30084233, PMID 30136447, PMID 30731474, PMID 32310620, PMID 32406112, PMID 33065589, PMID 34465695, PMID 35019221, PMID 36227782, PMID 36324245, PMID 38211604, PMID 38504394, PMID 38713137, PMID 38962910, PMID 40079184, PMID 40423516, PMID 41913506

NIH funding

2019 (2), N01CN00042 (1), P30CA014520 (1), UG1CA242635 (1)