The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).

Clinical Trial Description

This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic constipation (CIC). Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening. During this phase patients will be required to call in their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7 day period of BM diary calls, and continue to have less than 3 complete spontaneous movements per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880 patients will be randomized with the intent of having 200 patients per treatment group (each group the same size) included in efficacy analyses. All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01429987
Study type	Interventional
Source	Bausch Health Americas, Inc.
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	October 2011
Completion date	December 2012

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02361749` - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation	Phase 4
Terminated	`NCT02239510` - Efficacy of Linaclotide to Senna for CIC	N/A
Completed	`NCT01895543` - Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation	Phase 3
Completed	`NCT01460225` - Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation	Phase 4
Completed	`NCT02291679` - Trial of Linaclotide in Patients With Chronic Idiopathic Constipation	Phase 3
Completed	`NCT01993875` - Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation	Phase 3
Completed	`NCT01989234` - A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation	Phase 2
Completed	`NCT01674530` - Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation	Phase 3
Completed	`NCT01982240` - 12-Week Study of Plecanatide for CIC (The CIC3 Study)	Phase 3
Completed	`NCT02590432` - 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	Phase 4
Completed	`NCT02481947` - A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults	Phase 3
Completed	`NCT01372423` - Evaluation of Clinical Equivalence Between Two Lubiprostone Products	Phase 3
Completed	`NCT03054506` - The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation	N/A
Recruiting	`NCT04804267` - Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation	Phase 3
Completed	`NCT03879239` - Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation	N/A
Completed	`NCT01053962` - SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation	Phase 2
Completed	`NCT03097861` - Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo	Phase 3
Completed	`NCT03551873` - A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
Completed	`NCT02819310` - An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults	Phase 3
Completed	`NCT02819297` - BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults	Phase 3