Current partner codePEPTIDESDE

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Status

Completed

Phase

Phase 2 / Phase 3

Enrollment

951

Locations

121

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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).

Full detailed 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.

Interventions

Treatment arms and agents.

DRUG

plecanatide

Subjects receive experimental study drug for 12 weeks.

OTHER

Placebo

Subjects receive experimental study drug for 12 weeks.

Timeline

From registration to results.

  1. First posted

    Sep 7, 2011

  2. Study start

    Oct 2011

  3. Primary completion

    Dec 2012

  4. Study completion

    Dec 2012

  5. Results posted

    Nov 29, 2017

  6. Registry updated

    May 28, 2019

Outcomes

What the study measures.

Primary outcomes

Overall Responder 9/12 Weeks

Time frame · 12-Week Treatment Period

A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.

Secondary outcomes

Change From Baseline in 12-week CSBM Weekly Frequency Rate

Time frame · 12-Week Treatment Period

The number of Complete Spontaneous Bowel Movements (CSBMs) per week

Change From Baseline in 12-week SBM Weekly Frequency Rate

Time frame · 12-Week Treatment Period

The number of Spontaneous Bowl Movements experienced per week.

Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period

Time frame · 12-Week Treatment Period

The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid)

Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score

Time frame · 12-Week Treatment Period

The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Male or female aged 18-75, inclusive * Body Mass Index = 18-35 kg/m2, inclusive * Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for \>25% of defecations will not be eligible for participation. * Less than 3 CSBMs per week at baseline and during pretreatment * Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings * Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods * Willing to maintain a stable diet during the study. * Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study. Exclusion Criteria: * Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period * Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C) * Active peptic ulcer disease not adequately treated or not stable * History of cathartic colon, laxative, enema abuse, or ischemic colitis. * Fecal impaction within 3 months of screening * Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain * Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis. * Major surgery within 60 days of screening.

Study locations

121 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

East Valley Gastroenterology and Hepatology Associates, PC

Chandler, Arizona, United States

Genova Clinical Research

Tucson, Arizona, United States

Desert Sun Clinical Research, LLC

Tucson, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Preferred Research Partners, Inc

Little Rock, Arkansas, United States

ACRI-Phase 1,LLC

Anaheim, California, United States

Translational Research Group, INC., d/b/a Providence Clinical Research

Burbank, California, United States

GW Research, Inc

Chula Vista, California, United States

Community Clinical Trials

Orange, California, United States

Dormir Clinical Trials, Inc

Redlands, California, United States

Inland Gastroenterology Medical Associates, Inc.

Redlands, California, United States

Superior Research LLC

Sacramento, California, United States

Medical Center for Clinical Research

San Diego, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Progressive Clinical Research

Vista, California, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Consultants for Clinical Research of S. Florida

Boynton Beach, Florida, United States

Medical Research Unlimited, LLC

Hialeah, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Jupiter Research, Inc.

Jupiter, Florida, United States

Miami Gastroenterology Consultants, PA

Miami, Florida, United States

Advance Medical Research Service Corp

Miami, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Plecanatide.

Related PeptideStat pages

Put the record in context.

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