Irritable Bowel Syndrome Characterized by Constipation Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
The objective of this trial is to determine the efficacy and safety of linaclotide
administered to patients with irritable bowel syndrome with constipation (IBS-C).
The primary efficacy parameter is the percentage of patients in each treatment group that
meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement
(APC) Responder.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01622972 -
Mode of Action of Moviprep
|
Phase 4 | |
Recruiting |
NCT03687814 -
Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation
|
N/A | |
Completed |
NCT01722318 -
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
|
Phase 2 | |
Recruiting |
NCT04214470 -
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS
|
||
Completed |
NCT02493452 -
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 3 | |
Completed |
NCT03573908 -
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 3 | |
Recruiting |
NCT03226145 -
Reclassifying Constipation Using Imaging and Manometry
|
N/A | |
Completed |
NCT02732743 -
Food Supplement Physiomanna® Baby in Pediatric Patients
|
N/A | |
Terminated |
NCT02837783 -
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 4 | |
Not yet recruiting |
NCT03923322 -
Botanical Tincture for Symptoms of Irritable Bowel Syndrome
|
Phase 2 | |
Completed |
NCT02387359 -
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
|
Phase 3 |