Home
Clinical Trials
The Plecanatide Chronic Idiop...

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Last Updated: 2019-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

951 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02122471

Chronic Idiopathic Constipation

COMPLETED PHASE3

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

NCT01982240

Chronic Idiopathic Constipation

COMPLETED PHASE3

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

NCT01919697

Chronic Idiopathic Constipation

COMPLETED PHASE3

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

NCT03120520

Chronic Idiopathic Constipation

COMPLETED PHASE2

SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

NCT01053962

Chronic Idiopathic Constipation

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Idiopathic Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

plecanatide 0.3 mg

Subjects receive plecanatide 0.3 mg for 12 consecutive weeks

Group Type EXPERIMENTAL