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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01429987
Other study ID # SP304-20210
Secondary ID SP-SP30420210
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2011
Est. completion date December 2012

Study information

Verified date May 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 951
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
plecanatide
Subjects receive experimental study drug for 12 weeks.
Other:
Placebo
Subjects receive experimental study drug for 12 weeks.

Locations

Country Name City State
United States Albuquerque Clinical Trials, Inc Albuquerque New Mexico
United States Lovelace Scientific Resources, Inc Albuquerque New Mexico
United States ACRI-Phase 1,LLC Anaheim California
United States Heartland Research Associates, LLC Augusta Kansas
United States Gastroenterology Associates, LLC Baton Rouge Louisiana
United States Horizon Research Group, LLC Baton Rouge Louisiana
United States MediSpect, LLC Boone North Carolina
United States Boston Clinical Trials, Inc Boston Massachusetts
United States Consultants for Clinical Research of S. Florida Boynton Beach Florida
United States NY Total Medical Care Brooklyn New York
United States Synergy First Brooklyn New York
United States Investigators Research Group, LLC Brownsburg Indiana
United States Translational Research Group, INC., d/b/a Providence Clinical Research Burbank California
United States Valley Medical Research Centerville Ohio
United States East Valley Gastroenterology and Hepatology Associates, PC Chandler Arizona
United States Clinical and Translational Research Center Hospital Chapel Hill North Carolina
United States Carolina Digestive Health Associates Charlotte North Carolina
United States Ridgeview Research Chaska Minnesota
United States ClinSearch, LLC Chattanooga Tennessee
United States Clinical Research Institute of Michigan, LLC Chesterfield Michigan
United States Medex Healthcare Research, Inc. Chicago Illinois
United States New River Valley Research Institute Christiansburg Virginia
United States GW Research, Inc Chula Vista California
United States Iowa Digestive Disease Center Clive Iowa
United States Consultants in Gastroenerology Columbia South Carolina
United States Hometown Urgent Care Columbus Ohio
United States KRK Medical Research Dallas Texas
United States Research Across America Dallas Texas
United States Carolina Digestive Health Associates Davidson North Carolina
United States Hometown Urgent Care and Research Dayton Ohio
United States Gastro Specialists Research Center, LLC Decatur Georgia
United States Horizons Clinical Research Center, LLC Denver Colorado
United States CTL Research Eagle Idaho
United States Reasearch Across America El Paso Texas
United States Central Jersey Medical Research Center Elizabeth New Jersey
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States NECCR Internal Medicine and Cardiology Associates, LLC Fall River Massachusetts
United States Internal Medical Associates of Grand Island, PC Grand Island Nebraska
United States Long Island Gastrointestinal Research Group LLP Great Neck New York
United States LeBauer Research Associates, PA Greensboro North Carolina
United States Medoff Medical / Vital re:Search Greensboro North Carolina
United States Hometown Urgent Care Groveport Ohio
United States Carolina Digestive Health Associates Harrisburg North Carolina
United States Clinical Research Partners, LLC Henrico Virginia
United States Associates in Gastroenterology Hermitage Tennessee
United States Medical Research Unlimited, LLC Hialeah Florida
United States Mid-Atlantic Medical Research Centers Hollywood Maryland
United States Gastroenterology Consultants Houston Texas
United States Pioneer Research Solutions, Inc. Houston Texas
United States Hutchinson Clinic, P.A Hutchinson Kansas
United States Nature Coast Clinical Research Inverness Florida
United States HCCA Clinical Research Solutions Jackson Tennessee
United States Health Awareness, Inc. Jupiter Florida
United States Jupiter Research, Inc. Jupiter Florida
United States Beyer Research Kalamazoo Michigan
United States The Center for Pharmaceutical Research, PC Kansas City Missouri
United States Research Across America Katy Texas
United States PMG Research of Knoxville Knoxville Tennessee
United States Memorial Health System, Inc., d/b/a LaPorte Medical Group LaPorte Indiana
United States Midwest Center for Clinical Research Lee's Summit Missouri
United States Preferred Research Partners, Inc Little Rock Arkansas
United States DCOL Center for Clinical Research Longview Texas
United States Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia Lynchburg Virginia
United States South Jersey Gastroenterology, PA Marlton New Jersey
United States Great Lakes Gastroenterology Mentor Ohio
United States Advanced Clinical Research Meridian Idaho
United States Advance Medical Research Service Miami Florida
United States Advance Medical Research Service Corp Miami Florida
United States Columbus Clinical Services, LLC Miami Florida
United States Florida International Research Center Miami Florida
United States Miami Gastroenterology Consultants, PA Miami Florida
United States South Medical Research Group, Inc Miami Florida
United States Coastal Clinical Research, Inc. Mobile Alabama
United States Burke Primary Care Morgantown North Carolina
United States St. Thomas Medical Group Nashville Tennessee
United States Women Under Study, LLC New Orleans Louisiana
United States Heartland Research Associates, LLC Newton Kansas
United States National Clinical Research-Norfolk, Inc Norfolk Virginia
United States Southwest Gastroenterology Assoc Oak Lawn Illinois
United States Clinical Research Associates, LLC Oklahoma City Oklahoma
United States Quality Clinical Research Inc. Omaha Nebraska
United States Community Clinical Trials Orange California
United States Compass Research, LLC Orlando Florida
United States Research Integrity Owensboro Kentucky
United States Digestive Health Center Pasadena Texas
United States Gold Coast Research, LLC Plantation Florida
United States Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York
United States Wake Research associates, LLC Raleigh North Carolina
United States Dormir Clinical Trials, Inc Redlands California
United States Inland Gastroenterology Medical Associates, Inc. Redlands California
United States National Clinical Research-Richmond, Inc. Richmond Virginia
United States Jeffrey Danzig Ridgewood New Jersey
United States Remedica LLC Rochester Michigan
United States Rockford Gastroenterology Associates, Ltd. Rockford Illinois
United States Superior Research LLC Sacramento California
United States St. Louis Center for Clinical Research Saint Louis Missouri
United States Jean Brown Research Salt Lake City Utah
United States Utah Clinical Trials. LLC Salt Lake City Utah
United States Quality Research Inc. San Antonio Texas
United States Medical Associates Research Group, Inc. San Diego California
United States Medical Center for Clinical Research San Diego California
United States Mount Vernon Clinical Research, LLC Sandy Springs Georgia
United States DMI Research Seminole Florida
United States Willis-Knighton Physician Network / Pinnacle Gastroenterology Shreveport Louisiana
United States Memorial Health System, Inc., d/b/a Ireland Road Medical Group South Bend Indiana
United States American Center for Clinical Trials Southfield Michigan
United States Spring Gastroenterology PA Spring Texas
United States Hometown Urgent Care and Research Springfield Ohio
United States Meridien Research Tampa Florida
United States Adobe Clinical Research, LLC Tucson Arizona
United States Desert Sun Clinical Research, LLC Tucson Arizona
United States Genova Clinical Research Tucson Arizona
United States North American Partners in Pain Management Valley Stream New York
United States Progressive Clinical Research Vista California
United States Advanced Clinical Research West Jordan Utah
United States Palm Beach Research Center West Palm Beach Florida
United States Heartland Research Associates, LLC Wichita Kansas
United States Heartland Research Associates, LLC Wichita Kansas
United States PMG Research of Wilmington Wilmington North Carolina
United States PMG Research of Winston-Salem Winston-Salem North Carolina
United States Paddu and Associates, LLP Woodside New York

Sponsors (2)

Lead Sponsor Collaborator
Bausch Health Americas, Inc. Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change From Baseline in 12-week CSBM Weekly Frequency Rate The number of Complete Spontaneous Bowel Movements (CSBMs) per week 12-Week Treatment Period
Secondary Change From Baseline in 12-week SBM Weekly Frequency Rate The number of Spontaneous Bowl Movements experienced per week. 12-Week Treatment Period
Secondary Change From Baseline in Stool Consistency (BSFS) to Over 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.
= separate hard lumps like nuts (difficult to pass)
= sausage shaped but lumpy
= like a sausage but with cracks on its surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges (passed easily)
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces (entirely liquid)
12-Week Treatment Period
Secondary Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score 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 12-Week Treatment Period
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