Clinical trial NCT01429987: The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Official title: Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Idiopathic Constipation
Keywords: Chronic Idiopathic Constipation
Constipation
Sign and Symptoms: Digestive
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-09-07
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

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 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.

Primary outcomes:
measure: Overall Responder 9/12 Weeks
timeFrame: 12-Week Treatment Period
Secondary outcomes:
measure: Change From Baseline in 12-week CSBM Weekly Frequency Rate
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in 12-week SBM Weekly Frequency Rate
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
timeFrame: 12-Week Treatment Period
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: East Valley Gastroenterology and Hepatology Associates, PC
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc
state: Arkansas
city: Anaheim
country: United States
facility: ACRI-Phase 1,LLC
state: California
city: Burbank
country: United States
facility: Translational Research Group, INC., d/b/a Providence Clinical Research
state: California
city: Chula Vista
country: United States
facility: GW Research, Inc
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Redlands
country: United States
facility: Dormir Clinical Trials, Inc
state: California
city: Redlands
country: United States
facility: Inland Gastroenterology Medical Associates, Inc.
state: California
city: Sacramento
country: United States
facility: Superior Research LLC
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Vista
country: United States
facility: Progressive Clinical Research
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of S. Florida
state: Florida
city: Hialeah
country: United States
facility: Medical Research Unlimited, LLC
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Gastroenterology Consultants, PA
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Service Corp
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Service
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Miami
country: United States
facility: South Medical Research Group, Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Seminole
country: United States
facility: DMI Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Decatur
country: United States
facility: Gastro Specialists Research Center, LLC
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Eagle
country: United States
facility: CTL Research
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Medex Healthcare Research, Inc.
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology Assoc
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: LaPorte
country: United States
facility: Memorial Health System, Inc., d/b/a LaPorte Medical Group
state: Indiana
city: South Bend
country: United States
facility: Memorial Health System, Inc., d/b/a Ireland Road Medical Group
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Hutchinson
country: United States
facility: Hutchinson Clinic, P.A
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity
state: Kentucky
city: Baton Rouge
country: United States
facility: Horizon Research Group, LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network / Pinnacle Gastroenterology
state: Louisiana
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research Centers
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials, Inc
state: Massachusetts
city: Fall River
country: United States
facility: NECCR Internal Medicine and Cardiology Associates, LLC
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Rochester
country: United States
facility: Remedica LLC
state: Michigan
city: Southfield
country: United States
facility: American Center for Clinical Trials
state: Michigan
city: Chaska
country: United States
facility: Ridgeview Research
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: Lee's Summit
country: United States
facility: Midwest Center for Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Grand Island
country: United States
facility: Internal Medical Associates of Grand Island, PC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Marlton
country: United States
facility: South Jersey Gastroenterology, PA
state: New Jersey
city: Ridgewood
country: United States
facility: Jeffrey Danzig
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc
state: New Mexico
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc
state: New Mexico
city: Brooklyn
country: United States
facility: NY Total Medical Care
state: New York
city: Brooklyn
country: United States
facility: Synergy First
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Valley Stream
country: United States
facility: North American Partners in Pain Management
state: New York
city: Woodside
country: United States
facility: Paddu and Associates, LLP
state: New York
city: Boone
country: United States
facility: MediSpect, LLC
state: North Carolina
city: Chapel Hill
country: United States
facility: Clinical and Translational Research Center Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Davidson
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates, PA
state: North Carolina
city: Greensboro
country: United States
facility: Medoff Medical / Vital re:Search
state: North Carolina
city: Harrisburg
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Morgantown
country: United States
facility: Burke Primary Care
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Groveport
country: United States
facility: Hometown Urgent Care
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Springfield
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Associates, LLC
state: Oklahoma
city: Columbia
country: United States
facility: Consultants in Gastroenerology
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology
state: Tennessee
city: Jackson
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Medical Group
state: Tennessee
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: El Paso
country: United States
facility: Reasearch Across America
state: Texas
city: Houston
country: United States
facility: Gastroenterology Consultants
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Katy
country: United States
facility: Research Across America
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Pasadena
country: United States
facility: Digestive Health Center
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: Spring
country: United States
facility: Spring Gastroenterology PA
state: Texas
city: Salt Lake City
country: United States
facility: Utah Clinical Trials. LLC
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Henrico
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research-Norfolk, Inc
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research-Richmond, Inc.
state: Virginia
Study officials:
References: