The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Chronic Idiopathic Constipation Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

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