Clinical Trials Logo

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


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

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 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 NCT01993875 - Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation Phase 3
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