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

NCT01722318 | Completed Phase 2 Results

• 1 other identifier: SP304-20212
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 99

Brief Summary

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

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 weeks Treatment Period

Secondary Outcomes (3)

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

  12-Week Treatment Period

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

  12-Week Treatment Period

• Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)

  12-Week Treatment Period

Study Arms (5)

Plecanatide 0.3mg

ACTIVE COMPARATOR

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

Drug: Plecanatide

Plecanatide 1.0mg

ACTIVE COMPARATOR

Plecanatide 1.0mg one tablet by mouth daily for 12 weeks

Drug: Plecanatide

Plecanatide 3.0mg

ACTIVE COMPARATOR

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

Drug: Plecanatide

Plecanatide 9.0mg

ACTIVE COMPARATOR

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

Drug: Plecanatide

Placebo

PLACEBO COMPARATOR

Placebo, one tablet by mouth daily for 12 weeks

Drug: Placebo

Interventions

Plecanatide DRUG

Also known as: Trulance

Plecanatide 0.3mg; Plecanatide 1.0mg; Plecanatide 3.0mg; Plecanatide 9.0mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (99)

Cahaba Research

Birmingham, Alabama, 35242, United States

Location

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Arrowhead Family Health Center PC dba Arrowhead Health Centers

Glendale, Arizona, 85306, United States

Location

Advanced Research Associates, LLC

Glendale, Arizona, 85308, United States

Location

Elite Clinical Trials, LLC

Phoenix, Arizona, 85018, United States

Location

Genova Clinical Research, Inc.

Tucson, Arizona, 85704, United States

Location

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Advanced Rx Clinical Research, Inc.

Artesia, California, 90701, United States

Location

GW Research, Inc.

Chula Vista, California, 91910, United States

Location

SC Clinical Research, Inc.

Garden Grove, California, 92844, United States

Location

Grossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

Healthcare Partners Medical Group

Pasadena, California, 91105, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

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

Tustin, California, 92780, United States

Location

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80907, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Consultants for Clinical Research of South Florida

Boynton Beach, Florida, 33426, United States

Location

Medical Research Unlimited, LLC

Hialeah, Florida, 33012, United States

Location

Eastern Research, Inc

Hialeah, Florida, 33013, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Jupiter Research, Inc.

Jupiter, Florida, 33458, United States

Location

MNH Surgical Center

Maitland, Florida, 32751, United States

Location

San Marcus Research Clinic, Inc.

Miami, Florida, 33015, United States

Location

Genoma Research Group, Inc.

Miami, Florida, 33165, United States

Location

Columbus Clinical Services, LLC

Miami, Florida, 33174, United States

Location

South Medical Research Group, Inc.

Miami, Florida, 33186, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Urology Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Accord Clinical Research, LLC

Port Orange, Florida, 32129, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

CTL Research

Eagle, Idaho, 83616, United States

Location

Medex Healthcare Research, Inc

Chicago, Illinois, 60602, United States

Location

Rockford Gastroenterology Associates

Rockford, Illinois, 61107, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Delta Research Partners, LLC

Bastrop, Louisiana, 71220, United States

Location

Gastroenterology Research of New Orleans

Hammond, Louisiana, 70403, United States

Location

Centex Studies, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Women Under Study, LLC

New Orleans, Louisiana, 70115, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71103, United States

Location

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

Chevy Chase, Maryland, 20815, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Novex Clinical Research, LLC

New Bedford, Massachusetts, 02740, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

IHA Chelsea Family & Internal Medicine

Chelsea, Michigan, 48118, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Ridgeview Research

Chaska, Minnesota, 55318, United States

Location

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

The Center for Clinical Trials

Biloxi, Mississippi, 39531, United States

Location

Gastrointestinal Associates, PA

Jackson, Mississippi, 39202, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

Montana Health Research Institute, Inc.

Billings, Montana, 59102, United States

Location

Internal Medical Associates of Grand Island, PC

Grand Island, Nebraska, 68803, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

St. Luke's Hospital

New York, New York, 10025, United States

Location

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801, United States

Location

MediSpect Medical Research, LLC

Boone, North Carolina, 28607, United States

Location

Clinical Trials of North Carolina, LLC

Cary, North Carolina, 27518, United States

Location

Carolina Digestive Health Associates

Charlotte, North Carolina, 28210, United States

Location

On Site Clinical, LLC

Charlotte, North Carolina, 28277, United States

Location

Carolina Digestive Health Associates

Davidson, North Carolina, 28036, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, 28304, United States

Location

LeBauer Research Associates, P.A.

Greensboro, North Carolina, 27403, United States

Location

Medoff Medical / Vital re:Search

Greensboro, North Carolina, 27408, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Hometown Urgent Care and Occupational Health

Columbus, Ohio, 43214, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Consultants in Gastroenterology

Columbia, South Carolina, 29203, United States

Location

Southeast Medical Research

North Charleston, South Carolina, 29406, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Chattanooga Medical Research LLC

Chattanooga, Tennessee, 37404, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Franklin Gastroenterology, PLLC

Franklin, Tennessee, 37067, United States

Location

Memphis Gastroenterology Group, PC

Germantown, Tennessee, 38138, United States

Location

Associates in Gastroenterology

Hermitage, Tennessee, 37076, United States

Location

Austin Center for Clinical Research

Austin, Texas, 78756, United States

Location

DCT-AACT, LLC dba Discovery Clinical Trials

Austin, Texas, 78758, United States

Location

Texas Tech Medical Center

El Paso, Texas, 79905, United States

Location

Centex Studies, Inc.

Houston, Texas, 77062, United States

Location

North Texas Family Medicine

Plano, Texas, 75093, United States

Location

Quality Research, Inc.

San Antonio, Texas, 78209, United States

Location

Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute

San Antonio, Texas, 78228, United States

Location

Pioneer Research Solutions, Inc.

Sugar Land, Texas, 77479, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Interventions

plecanatide

Results Point of Contact

• Title: Dr. Patrick H. Griffin
• Organization: Synergy Pharmaceuticals Inc.

212-297-0020

Study Officials

• Philip B Miner, MD

  Oklahoma Foundation for Digestive Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 28, 2019
• Results First Posted: September 17, 2018

Record last verified: 2019-05

Locations

US (99)