The Plecanatide Chronic Idiopathic Constipation (CIC) Study

NCT01429987 | Completed Phase 2 Results

• 2 other identifiers: SP304-20210SP-SP30420210
• Study Type: interventional
• Target: 951
• Locations: 1 country
• Sites: 121

Brief Summary

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).

Conditions

Chronic Idiopathic Constipation

Keywords

Chronic Idiopathic Constipation; Constipation; Sign and Symptoms: Digestive

Outcome Measures

Primary Outcomes (1)

• Overall Responder 9/12 Weeks

  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.

  12-Week Treatment Period

Secondary Outcomes (4)

• Change From Baseline in 12-week CSBM Weekly Frequency Rate

  12-Week Treatment Period

• Change From Baseline in 12-week SBM Weekly Frequency Rate

  12-Week Treatment Period

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

  12-Week Treatment Period

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

  12-Week Treatment Period

Study Arms (4)

plecanatide 0.3 mg

EXPERIMENTAL

Subjects receive plecanatide 0.3 mg for 12 consecutive weeks

Drug: plecanatide

plecanatide 1.0 mg

EXPERIMENTAL

Subjects receive plecanatide 1.0 mg for 12 consecutive weeks

Drug: plecanatide

plecanatide 3.0 mg

EXPERIMENTAL

Subjects receive plecanatide 3.0 mg for 12 consecutive weeks

Drug: plecanatide

Placebo

PLACEBO COMPARATOR

Subjects receive placebo for 12 consecutive weeks

Other: Placebo

Interventions

plecanatide DRUG

Subjects receive experimental study drug for 12 weeks.

Also known as: Trulance

plecanatide 0.3 mg; plecanatide 1.0 mg; plecanatide 3.0 mg

Placebo OTHER

Subjects receive experimental study drug for 12 weeks.

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Parexel: collaborator

Study Sites (121)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

East Valley Gastroenterology and Hepatology Associates, PC

Chandler, Arizona, 85224, United States

Location

Genova Clinical Research

Tucson, Arizona, 85704, United States

Location

Desert Sun Clinical Research, LLC

Tucson, Arizona, 85710, United States

Location

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

Preferred Research Partners, Inc

Little Rock, Arkansas, 72211, United States

Location

ACRI-Phase 1,LLC

Anaheim, California, 92801, United States

Location

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

Burbank, California, 91505, United States

Location

GW Research, Inc

Chula Vista, California, 91910, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

Dormir Clinical Trials, Inc

Redlands, California, 92373, United States

Location

Inland Gastroenterology Medical Associates, Inc.

Redlands, California, 92374, United States

Location

Superior Research LLC

Sacramento, California, 95825, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

Location

Progressive Clinical Research

Vista, California, 92083, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Consultants for Clinical Research of S. Florida

Boynton Beach, Florida, 33426, United States

Location

Medical Research Unlimited, LLC

Hialeah, Florida, 33012, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Jupiter Research, Inc.

Jupiter, Florida, 33458, United States

Location

Miami Gastroenterology Consultants, PA

Miami, Florida, 33156, United States

Location

Advance Medical Research Service Corp

Miami, Florida, 33165, United States

Location

Advance Medical Research Service

Miami, Florida, 33165, United States

Location

Florida International Research Center

Miami, Florida, 33166, 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

Gold Coast Research, LLC

Plantation, Florida, 33317, United States

Location

DMI Research

Seminole, Florida, 33777, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Gastro Specialists Research Center, LLC

Decatur, Georgia, 30032, United States

Location

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

CTL Research

Eagle, Idaho, 83616, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Medex Healthcare Research, Inc.

Chicago, Illinois, 60602, United States

Location

Southwest Gastroenterology Assoc

Oak Lawn, Illinois, 60453, United States

Location

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107, United States

Location

Investigators Research Group, LLC

Brownsburg, Indiana, 46112, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Memorial Health System, Inc., d/b/a LaPorte Medical Group

La Porte, Indiana, 46350, United States

Location

Memorial Health System, Inc., d/b/a Ireland Road Medical Group

South Bend, Indiana, 46614, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Hutchinson Clinic, P.A

Hutchinson, Kansas, 67502, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Research Integrity

Owensboro, Kentucky, 42303, United States

Location

Horizon Research Group, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Women Under Study, LLC

New Orleans, Louisiana, 70115, United States

Location

Willis-Knighton Physician Network / Pinnacle Gastroenterology

Shreveport, Louisiana, 71103, United States

Location

Mid-Atlantic Medical Research Centers

Hollywood, Maryland, 20636, United States

Location

Boston Clinical Trials, Inc

Boston, Massachusetts, 02135, United States

Location

NECCR Internal Medicine and Cardiology Associates, LLC

Fall River, Massachusetts, 02720, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Remedica LLC

Rochester, Michigan, 48307, United States

Location

American Center for Clinical Trials

Southfield, Michigan, 48034, United States

Location

Ridgeview Research

Chaska, Minnesota, 55318, United States

Location

The Center for Pharmaceutical Research, PC

Kansas City, Missouri, 64114, United States

Location

Midwest Center for Clinical Research

Lee's Summit, Missouri, 64064, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, 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

Central Jersey Medical Research Center

Elizabeth, New Jersey, 07202, United States

Location

South Jersey Gastroenterology, PA

Marlton, New Jersey, 08053, United States

Location

Jeffrey Danzig

Ridgewood, New Jersey, 07450, United States

Location

Albuquerque Clinical Trials, Inc

Albuquerque, New Mexico, 87102, United States

Location

Lovelace Scientific Resources, Inc

Albuquerque, New Mexico, 87108, United States

Location

NY Total Medical Care

Brooklyn, New York, 11215, United States

Location

Synergy First

Brooklyn, New York, 11230, United States

Location

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023, United States

Location

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, 12601, United States

Location

North American Partners in Pain Management

Valley Stream, New York, 11580, United States

Location

Paddu and Associates, LLP

Woodside, New York, 11377, United States

Location

MediSpect, LLC

Boone, North Carolina, 28607, United States

Location

Clinical and Translational Research Center Hospital

Chapel Hill, North Carolina, 27599-7600, United States

Location

Carolina Digestive Health Associates

Charlotte, North Carolina, 28210, United States

Location

Carolina Digestive Health Associates

Davidson, North Carolina, 28036, United States

Location

LeBauer Research Associates, PA

Greensboro, North Carolina, 27403, United States

Location

Medoff Medical / Vital re:Search

Greensboro, North Carolina, 27408, United States

Location

Carolina Digestive Health Associates

Harrisburg, North Carolina, 28075, United States

Location

Burke Primary Care

Morgantown, North Carolina, 28655, United States

Location

Wake Research associates, LLC

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Valley Medical Research

Centerville, Ohio, 45459, United States

Location

Hometown Urgent Care

Columbus, Ohio, 43214, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45432, United States

Location

Hometown Urgent Care

Groveport, Ohio, 43125, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Hometown Urgent Care and Research

Springfield, Ohio, 45504, United States

Location

Clinical Research Associates, LLC

Oklahoma City, Oklahoma, 73112, United States

Location

Consultants in Gastroenerology

Columbia, South Carolina, 29203, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Associates in Gastroenterology

Hermitage, Tennessee, 37076, United States

Location

HCCA Clinical Research Solutions

Jackson, Tennessee, 38305, United States

Location

PMG Research of Knoxville

Knoxville, Tennessee, 37912, United States

Location

St. Thomas Medical Group

Nashville, Tennessee, 37205, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Reasearch Across America

El Paso, Texas, 79902, United States

Location

Gastroenterology Consultants

Houston, Texas, 77034, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77098, United States

Location

Research Across America

Katy, Texas, 77450, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Digestive Health Center

Pasadena, Texas, 77505, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Spring Gastroenterology PA

Spring, Texas, 77386, United States

Location

Utah Clinical Trials. LLC

Salt Lake City, Utah, 84107, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

Clinical Research Partners, LLC

Henrico, Virginia, 23233, United States

Location

Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia

Lynchburg, Virginia, 24502, United States

Location

National Clinical Research-Norfolk, Inc

Norfolk, Virginia, 23502, United States

Location

National Clinical Research-Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Constipation

Interventions

plecanatide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

212-297-0020

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 7, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 28, 2019
• Results First Posted: November 29, 2017

Record last verified: 2019-05

Locations

US (121)