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

NCT ID: NCT01722318

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-10-31

Brief Summary

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

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).

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Plecanatide 0.3mg

Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Plecanatide

Intervention Type: DRUG

Plecanatide 1.0mg

Plecanatide 1.0mg one tablet by mouth daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Plecanatide

Intervention Type: DRUG

Plecanatide 3.0mg

Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Plecanatide

Intervention Type: DRUG

Plecanatide 9.0mg

Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Plecanatide

Intervention Type: DRUG

Placebo

Placebo, one tablet by mouth daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Plecanatide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Trulance

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip B Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Foundation for Digestive Research

Locations

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

MNH Surgical Center

Maitland, Florida, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Genoma Research Group, Inc.

Miami, Florida, United States

Columbus Clinical Services, LLC

Miami, Florida, United States

South Medical Research Group, Inc.

Miami, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

Urology Center of Florida

Pompano Beach, Florida, United States

Accord Clinical Research, LLC

Port Orange, Florida, United States

Meridien Research

Tampa, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Clinical Research of Central Florida

Winter Haven, Florida, United States

Georgia Regents University

Augusta, Georgia, United States

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

CTL Research

Eagle, Idaho, United States

Medex Healthcare Research, Inc

Chicago, Illinois, United States

Rockford Gastroenterology Associates

Rockford, Illinois, United States

Heartland Research Associates, LLC

Augusta, Kansas, United States

Research Integrity, LLC

Owensboro, Kentucky, United States

Delta Research Partners, LLC

Bastrop, Louisiana, United States

Gastroenterology Research of New Orleans

Hammond, Louisiana, United States

Centex Studies, Inc.

Lake Charles, Louisiana, United States

Women Under Study, LLC

New Orleans, Louisiana, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Novex Clinical Research, LLC

New Bedford, Massachusetts, United States

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, United States

IHA Chelsea Family & Internal Medicine

Chelsea, Michigan, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Center for Digestive Health

Troy, Michigan, United States

Ridgeview Research

Chaska, Minnesota, United States

Prism Research

Saint Paul, Minnesota, United States

The Center for Clinical Trials

Biloxi, Mississippi, United States

Gastrointestinal Associates, PA

Jackson, Mississippi, United States

St. Louis Center for Clinical Research

St Louis, Missouri, United States

Montana Health Research Institute, Inc.

Billings, Montana, United States

Internal Medical Associates of Grand Island, PC

Grand Island, Nebraska, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

St. Luke's Hospital

New York, New York, United States

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, United States

MediSpect Medical Research, LLC

Boone, North Carolina, United States

Clinical Trials of North Carolina, LLC

Cary, North Carolina, United States

Carolina Digestive Health Associates

Charlotte, North Carolina, United States

On Site Clinical, LLC

Charlotte, North Carolina, United States

Carolina Digestive Health Associates

Davidson, North Carolina, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

LeBauer Research Associates, P.A.

Greensboro, North Carolina, United States

Medoff Medical / Vital re:Search

Greensboro, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Hometown Urgent Care and Occupational Health

Columbus, Ohio, United States

Great Lakes Gastroenterology

Mentor, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Options Health Research, LLC

Tulsa, Oklahoma, United States

Consultants in Gastroenterology

Columbia, South Carolina, United States

Southeast Medical Research

North Charleston, South Carolina, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Chattanooga Medical Research LLC

Chattanooga, Tennessee, United States

ClinSearch, LLC

Chattanooga, Tennessee, United States

Franklin Gastroenterology, PLLC

Franklin, Tennessee, United States

Memphis Gastroenterology Group, PC

Germantown, Tennessee, United States

Associates in Gastroenterology

Hermitage, Tennessee, United States

Austin Center for Clinical Research

Austin, Texas, United States

DCT-AACT, LLC dba Discovery Clinical Trials

Austin, Texas, United States

Texas Tech Medical Center

El Paso, Texas, United States

Centex Studies, Inc.

Houston, Texas, United States

North Texas Family Medicine

Plano, Texas, United States

Quality Research, Inc.

San Antonio, Texas, United States

Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute

San Antonio, Texas, United States

Pioneer Research Solutions, Inc.

Sugar Land, Texas, United States

New River Valley Research Institute

Christiansburg, Virginia, United States

Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia

Lynchburg, Virginia, United States

Countries

United States

Other Identifiers

SP304-20212

Identifier Type: -

Identifier Source: org_study_id