Current partner codePEPTIDESDE
NCT01722318·Phase 2·INTERVENTIONAL

The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

Status

Completed

Phase

Phase 2

Enrollment

428

Locations

99

Results

Posted

Publications

0

Study summary

What the protocol is testing.

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.

Full detailed description

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).

Interventions

Treatment arms and agents.

DRUG

Plecanatide

DRUG

Placebo

Timeline

From registration to results.

  1. First posted

    Nov 6, 2012

  2. Study start

    Nov 2012

  3. Primary completion

    Apr 2014

  4. Study completion

    Oct 2014

  5. Results posted

    Sep 17, 2018

  6. Registry updated

    May 28, 2019

Outcomes

What the study measures.

Primary outcomes

Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)

Time frame · 12 weeks Treatment Period

The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 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.

Secondary outcomes

Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)

Time frame · 12-Week Treatment Period

Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.

Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)

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 Straining Scores Over 12-Week Treatment Period (mITT Population)

Time frame · 12-Week Treatment Period

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

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 irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months. * Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months. * Hard or lumpy stools ≥ 25 % of defecations * Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period * 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 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 pre-treatment period * Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS. * 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: 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

99 registered sites.

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

Cahaba Research

Birmingham, Alabama, United States

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Arrowhead Family Health Center PC dba Arrowhead Health Centers

Glendale, Arizona, United States

Advanced Research Associates, LLC

Glendale, Arizona, United States

Elite Clinical Trials, LLC

Phoenix, Arizona, United States

Genova Clinical Research, Inc.

Tucson, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Advanced Rx Clinical Research, Inc.

Artesia, California, United States

GW Research, Inc.

Chula Vista, California, United States

SC Clinical Research, Inc.

Garden Grove, California, United States

Grossmont Center for Clinical Research

La Mesa, California, United States

Community Clinical Trials

Orange, California, United States

Healthcare Partners Medical Group

Pasadena, California, United States

Medical Center for Clinical Research

San Diego, California, United States

Memorial Research Medical Clinic d/b/a Orange Country Research Center

Tustin, California, United States

Lynn Institute of the Rockies

Colorado Springs, Colorado, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Consultants for Clinical Research of South Florida

Boynton Beach, Florida, United States

Medical Research Unlimited, LLC

Hialeah, Florida, United States

Eastern Research, Inc

Hialeah, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Jupiter Research, Inc.

Jupiter, 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.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.