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

Irritable Bowel Syndrome Characterized by Constipation Clinical Trial

— CIBS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722318
• Other study ID #: SP304-20212
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: October 2014

Study information

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

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• 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 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.

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Characterized by Constipation
• Syndrome

Intervention

Drug:
• Plecanatide

• Placebo

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Advanced Rx Clinical Research, Inc.	Artesia	California
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Georgia Regents University	Augusta	Georgia
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Austin Center for Clinical Research	Austin	Texas
United States	DCT-AACT, LLC dba Discovery Clinical Trials	Austin	Texas
United States	Delta Research Partners, LLC	Bastrop	Louisiana
United States	Montana Health Research Institute, Inc.	Billings	Montana
United States	The Center for Clinical Trials	Biloxi	Mississippi
United States	Cahaba Research	Birmingham	Alabama
United States	MediSpect Medical Research, LLC	Boone	North Carolina
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Consultants for Clinical Research of South Florida	Boynton Beach	Florida
United States	Clinical Trials of North Carolina, LLC	Cary	North Carolina
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	On Site Clinical, LLC	Charlotte	North Carolina
United States	Ridgeview Research	Chaska	Minnesota
United States	Chattanooga Medical Research LLC	Chattanooga	Tennessee
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	IHA Chelsea Family & Internal Medicine	Chelsea	Michigan
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland
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	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Consultants in Gastroenterology	Columbia	South Carolina
United States	Hometown Urgent Care and Occupational Health	Columbus	Ohio
United States	Carolina Digestive Health Associates	Davidson	North Carolina
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	CTL Research	Eagle	Idaho
United States	Texas Tech Medical Center	El Paso	Texas
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Franklin Gastroenterology, PLLC	Franklin	Tennessee
United States	SC Clinical Research, Inc.	Garden Grove	California
United States	Memphis Gastroenterology Group, PC	Germantown	Tennessee
United States	Advanced Research Associates, LLC	Glendale	Arizona
United States	Arrowhead Family Health Center PC dba Arrowhead Health Centers	Glendale	Arizona
United States	Internal Medical Associates of Grand Island, PC	Grand Island	Nebraska
United States	LeBauer Research Associates, P.A.	Greensboro	North Carolina
United States	Medoff Medical / Vital re:Search	Greensboro	North Carolina
United States	Gastroenterology Research of New Orleans	Hammond	Louisiana
United States	Associates in Gastroenterology	Hermitage	Tennessee
United States	Eastern Research, Inc	Hialeah	Florida
United States	Medical Research Unlimited, LLC	Hialeah	Florida
United States	Centex Studies, Inc.	Houston	Texas
United States	Gastrointestinal Associates, PA	Jackson	Mississippi
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Jupiter Research, Inc.	Jupiter	Florida
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Centex Studies, Inc.	Lake Charles	Louisiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia	Lynchburg	Virginia
United States	MNH Surgical Center	Maitland	Florida
United States	Great Lakes Gastroenterology	Mentor	Ohio
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	Genoma Research Group, Inc.	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	South Medical Research Group, Inc.	Miami	Florida
United States	Novex Clinical Research, LLC	New Bedford	Massachusetts
United States	Women Under Study, LLC	New Orleans	Louisiana
United States	St. Luke's Hospital	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	Southeast Medical Research	North Charleston	South Carolina
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma Foundation for Digestive Research	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, LLC	Owensboro	Kentucky
United States	Healthcare Partners Medical Group	Pasadena	California
United States	Elite Clinical Trials, LLC	Phoenix	Arizona
United States	North Texas Family Medicine	Plano	Texas
United States	Urology Center of Florida	Pompano Beach	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Rockford Gastroenterology Associates	Rockford	Illinois
United States	St. Louis Center for Clinical Research	Saint Louis	Missouri
United States	Prism Research	Saint Paul	Minnesota
United States	Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute	San Antonio	Texas
United States	Quality Research, Inc.	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Pioneer Research Solutions, Inc.	Sugar Land	Texas
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Meridien Research	Tampa	Florida
United States	Center for Digestive Health	Troy	Michigan
United States	Adobe Clinical Research, LLC	Tucson	Arizona
United States	Genova Clinical Research, Inc.	Tucson	Arizona
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Memorial Research Medical Clinic d/b/a Orange Country Research Center	Tustin	California
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)	Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.	12-Week Treatment Period
Secondary	Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)	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 Straining Scores Over 12-Week Treatment Period (mITT Population)	The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe	12-Week Treatment Period