Plecanatide

DRUG14 trials

Sponsors

Bausch Health Americas, Inc., University of Wisconsin, Madison, Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Conditions

Barrett EsophagusChronic Idiopathic ConstipationFunctional ConstipationFunctional Constipation (FC)Gastroesophageal Reflux DiseaseIrritable Bowel SyndromeIrritable Bowel Syndrome Characterized by ConstipationIrritable Bowel Syndrome With Constipation

Phase 1

GCC Agonist Signal in the Small Intestine

CompletedNCT05107219

University of Wisconsin, MadisonBarrett Esophagus, Gastroesophageal Reflux Disease, Malignant Digestive System Neoplasm

Start: 2022-11-30End: 2026-02-06Updated: 2026-04-07

Phase 2

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

CompletedNCT01429987

Bausch Health Americas, Inc.Chronic Idiopathic Constipation

Start: 2011-10-31End: 2012-12-31Updated: 2019-05-28

The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

CompletedNCT01722318

Bausch Health Americas, Inc.Irritable Bowel Syndrome Characterized by Constipation

Start: 2012-11-30End: 2014-10-31Updated: 2019-05-28

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

CompletedNCT03120520

Bausch Health Americas, Inc.Chronic Idiopathic Constipation

Start: 2017-01-31End: 2018-09-07Updated: 2019-10-04

Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedNCT03596905

Bausch Health Americas, Inc.Irritable Bowel Syndrome With Constipation

Start: 2018-06-30End: 2024-11-25Updated: 2025-12-31

This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC

Active, not recruitingNCT07723924

Bausch Health Americas, Inc.Functional Constipation (FC)

Start: 2026-06-01End: 2027-10-18Target: 180Updated: 2026-07-23

Phase 3

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

CompletedNCT01919697

Bausch Health Americas, Inc.Chronic Idiopathic Constipation

Start: 2013-08-31End: 2016-03-31Updated: 2019-07-02

12-Week Study of Plecanatide for CIC (The CIC3 Study)

CompletedNCT01982240

Bausch Health Americas, Inc.Chronic Idiopathic Constipation

Start: 2013-11-30End: 2015-06-30Updated: 2019-12-26

12-Week Study of Plecanatide for CIC (The National CIC3 Study)

CompletedNCT02122471

Bausch Health Americas, Inc.Chronic Idiopathic Constipation

Start: 2014-04-30End: 2015-07-31Updated: 2019-05-28

The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

CompletedNCT02387359

Bausch Health Americas, Inc.Irritable Bowel Syndrome Characterized by Constipation

Start: 2014-12-31End: 2017-02-28Updated: 2019-06-14

Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedNCT02493452

Bausch Health Americas, Inc.Irritable Bowel Syndrome Characterized by Constipation

Start: 2015-06-30End: 2017-02-28Updated: 2019-06-14

Long Term Safety Study of Plecanatide

CompletedNCT02706483

Bausch Health Americas, Inc.Irritable Bowel Syndrome

Start: 2016-01-31End: 2017-06-30Updated: 2020-08-18

Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation

CompletedNCT05151328

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Functional Constipation

Start: 2022-03-18End: 2023-10-26Updated: 2024-07-11

Unknown Phase

A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

CompletedNCT03551873

Bausch Health Americas, Inc.Chronic Idiopathic Constipation

Start: 2018-06-21End: 2018-12-14Updated: 2019-11-22

Related Papers

The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint.

2025-11-101 citations

S532 Plecanatide Improves Severe Abdominal Pain and Severe Bloating in Individuals With Irritable Bowel Syndrome With Constipation (IBS-C): A Pooled Analysis of Two Phase 3 Trials

The American Journal of Gastroenterology2022-10-01

S534 Plecanatide Improves Symptoms of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome With Constipation (IBS-C) Across Age Subgroups: An Analysis of Four Phase 3 Trials

The American Journal of Gastroenterology2022-10-01

The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials.

2022-01-25

S527 Plecanatide Produces a More Rapid and Durable Clinical Response Compared to Placebo in Patients With Chronic Idiopathic Constipation: A Post-Hoc Analysis of Two Randomized Controlled Trials

The American Journal of Gastroenterology2021-10-01

S0486 Efficacy and Safety of Plecanatide in Patients With Chronic Idiopathic Constipation or Irritable Bowel Syndrome With Constipation: Intrinsic Factors Analyses From Four Studies

The American Journal of Gastroenterology2020-10-01

Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older

Clinical Therapeutics2020-07-0112 citations

Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation

Current Medical Research and Opinion2018-10-029 citations

Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation

Therapeutic Advances in Gastroenterology2017-10-2570 citations

A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation

The American Journal of Gastroenterology2017-02-07137 citations