14 completed, 1 active not recruiting. 8 Phase 3, 6 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 8 |
| Phase 2 | 6 | Completed 5, Active not recruiting 1 |
| Phase 1 | 1 | Completed 1 |
Follow plecanatide: new trials by email Literature Review of plecanatide trials Research Report on plecanatide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 plecanatide, Placebo - Functional Constipation (FC) | Phase 2 | Active not recruiting | Bausch Health Americas, Inc. | 180 | 2026-08-18 | 2026-10-29 |
| GCC Agonist Signal in the Small Intestine Biopsy, Biospecimen Collection, Esophagogastroduodenoscopy - Barrett Esophagus, Gastroesophageal Reflux Disease | Phase 1 | Completed | University of Wisconsin, Madison | 43 | 2022-11-30 | 2026-04-07 |
| Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation Plecanatide - Functional Constipation | Phase 3 | Completed | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | 648 | 2022-03-18 | 2024-07-11 |
| Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C) Plecanatide, Matching placebo - Irritable Bowel Syndrome With Constipation | Phase 2 | Completed | Bausch Health Americas, Inc. | 218 | 2018-06-30 | 2025-12-31 |
| A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE® Plecanatide - Chronic Idiopathic Constipation | Completed | Bausch Health Americas, Inc. | 7 | 2018-06-21 | 2019-11-22 | |
| An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation Plecanatide, Matching placebo - Chronic Idiopathic Constipation | Phase 2 | Completed | Bausch Health Americas, Inc. | 124 | 2017-01-01 | 2019-10-04 |
| Long Term Safety Study of Plecanatide Plecanatide - Irritable Bowel Syndrome | Phase 3 | Completed | Bausch Health Americas, Inc. | 2272 | 2016-01-01 | 2020-08-18 |
| Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C) Plecanatide, Placebo - Irritable Bowel Syndrome Characterized by Constipation | Phase 3 | Completed | Bausch Health Americas, Inc. | 1135 | 2015-06-01 | 2019-06-14 |
| The Plecanatide Irritable Bowel Syndrome With Constipation Safety and Efficacy Study (IBS-C) Plecanatide, Placebo - Irritable Bowel Syndrome Characterized by Constipation | Phase 3 | Completed | Bausch Health Americas, Inc. | 1054 | 2014-12-01 | 2026-10-20 |
| 12-Week Study of Plecanatide for CIC (The National CIC3 Study) Plecanatide, Placebo - Chronic Idiopathic Constipation | Phase 3 | Completed | Bausch Health Americas, Inc. | 1410 | 2014-04-01 | 2019-05-28 |
| 12-Week Study of Plecanatide for CIC (The CIC3 Study) Plecanatide, Placebo, Bisacodyl - Chronic Idiopathic Constipation | Phase 3 | Completed | Bausch Health Americas, Inc. | 1394 | 2013-11-01 | 2019-12-26 |
| Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) Plecanatide - Chronic Idiopathic Constipation | Phase 3 | Completed | Bausch Health Americas, Inc. | 2370 | 2013-08-01 | 2019-07-02 |
| The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) Plecanatide, Placebo - Irritable Bowel Syndrome Characterized by Constipation | Phase 2 | Completed | Bausch Health Americas, Inc. | 428 | 2012-11-01 | 2019-05-28 |
| The Plecanatide Chronic Idiopathic Constipation (CIC) Study plecanatide, Placebo - Chronic Idiopathic Constipation | Phase 2 / Phase 3 | Completed | Bausch Health Americas, Inc. | 951 | 2011-10-01 | 2019-05-28 |
| SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation SP-304 0.3 mg, SP-304 1.0 mg, SP-304 3.0 mg - Chronic Idiopathic Constipation | Phase 2 | Completed | Bausch Health Americas, Inc. | 84 | 2010-03-01 | 2020-01-02 |
Constipation (6) · Irritable Bowel Syndrome (2) · Barrett Esophagus (1) · Bronchiolitis Obliterans Syndrome (1) · Gastroesophageal Reflux (1) · Gastrointestinal Neoplasms (1)
Bausch Health Americas, Inc. (13) · Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (1) · University of Wisconsin, Madison (1)
United States (14) · Canada (2) · China (1)
Mary Beth Layton (2) · Paul F.C. Eng, PhD (2) · Angela Bulawski (1) · Anhthu Nguyen (1) · David S Weinberg (1) · Gary S Jacob, Ph.D. (1) · Philip B Miner, MD (1) · Richard A Krause, MD (1)
PMID 32660770, PMID 37332239, PMID 35086735, PMID 41214272, PMID 28169285, PMID 29147135, PMID 29343131, PMID 30277094, PMID 37162147
P30CA014520 (1), UG1CA242635 (1)