Clinical trial NCT01722318: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Official title: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 428
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, 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).

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.

Primary outcomes:
measure: Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
timeFrame: 12 weeks Treatment Period
Secondary outcomes:
measure: Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)
timeFrame: 12-Week Treatment Period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Glendale
country: United States
facility: Arrowhead Family Health Center PC dba Arrowhead Health Centers
state: Arizona
city: Glendale
country: United States
facility: Advanced Research Associates, LLC
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Trials, LLC
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Artesia
country: United States
facility: Advanced Rx Clinical Research, Inc.
state: California
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Garden Grove
country: United States
facility: SC Clinical Research, Inc.
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Pasadena
country: United States
facility: Healthcare Partners Medical Group
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Tustin
country: United States
facility: Memorial Research Medical Clinic d/b/a Orange Country Research Center
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
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 South Florida
state: Florida
city: Hialeah
country: United States
facility: Medical Research Unlimited, LLC
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc
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: Maitland
country: United States
facility: MNH Surgical Center
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc.
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: Pompano Beach
country: United States
facility: Urology Center of Florida
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
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: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
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: Chicago
country: United States
facility: Medex Healthcare Research, Inc
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates
state: Illinois
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Bastrop
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Hammond
country: United States
facility: Gastroenterology Research of New Orleans
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: New Bedford
country: United States
facility: Novex Clinical Research, LLC
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Chelsea
country: United States
facility: IHA Chelsea Family & Internal Medicine
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Chaska
country: United States
facility: Ridgeview Research
state: Minnesota
city: Saint Paul
country: United States
facility: Prism Research
state: Minnesota
city: Biloxi
country: United States
facility: The Center for Clinical Trials
state: Mississippi
city: Jackson
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Billings
country: United States
facility: Montana Health Research Institute, Inc.
state: Montana
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: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: St. Luke's Hospital
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Boone
country: United States
facility: MediSpect Medical Research, LLC
state: North Carolina
city: Cary
country: United States
facility: Clinical Trials of North Carolina, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Charlotte
country: United States
facility: On Site Clinical, LLC
state: North Carolina
city: Davidson
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates, P.A.
state: North Carolina
city: Greensboro
country: United States
facility: Medoff Medical / Vital re:Search
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Columbus
country: United States
facility: Hometown Urgent Care and Occupational Health
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Columbia
country: United States
facility: Consultants in Gastroenterology
state: South Carolina
city: North Charleston
country: United States
facility: Southeast Medical Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research LLC
state: Tennessee
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Franklin
country: United States
facility: Franklin Gastroenterology, PLLC
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology
state: Tennessee
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: DCT-AACT, LLC dba Discovery Clinical Trials
state: Texas
city: El Paso
country: United States
facility: Texas Tech Medical Center
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia
state: Virginia
Study officials:
affiliation: Oklahoma Foundation for Digestive Research
name: Philip B Miner, MD
role: PRINCIPAL_INVESTIGATOR
References: