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

Irritable Bowel Syndrome Characterized by Constipation Clinical Trial

— IBS-C  

Official title:

Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of 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: NCT02493452
• Other study ID #: SP304203-05
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: February 2017

Study information

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

Clinical Trial Summary

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Description:

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.

Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.

Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.

The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1135
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

• Refusal or inability to sign informed consent for the trial

• Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires

• BMI = 40 or < 18

• Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial

• Women who are pregnant or lactating

• Diagnosis of IBS-D or IBS-M

• Organic or obstructive disease of the small or large intestine

• Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)

• Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication

• Unstable medical illness

• Bilirubin > 3X ULN in the absence of a conjugation defect

• Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor

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	Synergy Research Site	Albuquerque	New Mexico
United States	Synergy Research Site	Anderson	South Carolina
United States	Synergy Research Site	Annapolis	Maryland
United States	Synergy Research Site	Atlanta	Georgia
United States	Synergy Research Site	Atlanta	Georgia
United States	Synergy Research Site	Atlantis	Florida
United States	Synergy Research Site	Austin	Texas
United States	Synergy Research Site	Austin	Texas
United States	Synergy Research Site	Baytown	Texas
United States	Synergy Research Site	Beaumont	Texas
United States	Synergy Research Site	Birmingham	Alabama
United States	Synergy Research Site	Birmingham	Alabama
United States	Synergy Research Site	Blackfoot	Idaho
United States	Synergy Research Site	Blackwood	New Jersey
United States	Synergy Research Site	Blue Island	Illinois
United States	Synergy Research Site	Boca Raton	Florida
United States	Synergy Research Site	Boise	Idaho
United States	Synergy Research Site	Bradenton	Florida
United States	Synergy Research Site	Brandon	Florida
United States	Synergy Research Site	Brooksville	Florida
United States	Synergy Research Site	Brownsburg	Indiana
United States	Synergy Research Site	Canoga Park	California
United States	Synergy Research Site	Carmichael	California
United States	Synergy Research Site	Catonsville	Maryland
United States	Synergy Research Site	Channelview	Texas
United States	Synergy Research Site	Chapel Hill	North Carolina
United States	Synergy Research Site	Chesapeake	Virginia
United States	Synergy Research Site	Chesterfield	Missouri
United States	Synergy Research Site	Chicago	Illinois
United States	Synergy Research Site	Chino	California
United States	Synergy Research Site	Chula Vista	California
United States	Synergy Research Site	Cincinnati	Ohio
United States	Synergy Research Site	Cincinnati	Ohio
United States	Synergy Research Site	Cincinnati	Ohio
United States	Synergy Research Site	Clearwater	Florida
United States	Synergy Research Site	Colorado Springs	Colorado
United States	Synergy Research Site	Columbus	Ohio
United States	Synergy Research Site	Conway	Arkansas
United States	Synergy Research Site	Cutler Bay	Florida
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dayton	Ohio
United States	Synergy Research Site	Dayton	Ohio
United States	Synergy Research Site	Decatur	Georgia
United States	Synergy Research Site	Denver	Colorado
United States	Synergy Research Site	Doylestown	Pennsylvania
United States	Synergy Research Site	Egg Harbor Township	New Jersey
United States	Synergy Research Site	El Cajon	California
United States	Synergy Research Site	Encino	California
United States	Synergy Research Site	Evanston	Illinois
United States	Synergy Research Site	Fairfax	Virginia
United States	Synergy Research Site	Fayetteville	Tennessee
United States	Synergy Research Site	Fayetteville	North Carolina
United States	Synergy Research Site	Foothill Ranch	California
United States	Synergy Research Site	Fort Lauderdale	Florida
United States	Synergy Research Site	Fort Lauderdale	Florida
United States	Synergy Research Site	Franklin	Tennessee
United States	Synergy Research Site	Franklin	Ohio
United States	Synergy Research Site	Garden Grove	California
United States	Synergy Research Site	Glendale	Arizona
United States	Synergy Research Site	Greer	South Carolina
United States	Synergy Research Site	Guntersville	Alabama
United States	Synergy Research Site	Hamden	Connecticut
United States	Synergy Research Site	Hermitage	Tennessee
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	High Point	North Carolina
United States	Synergy Research Site	Hoffman Estates	Illinois
United States	Synergy Research Site	Hopewell Junction	New York
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Humble	Texas
United States	Synergy Research Site	Huntington Beach	California
United States	Synergy Research Site	Huntsville	Alabama
United States	Synergy Research Site	Indianapolis	Indiana
United States	Synergy Research Site	Irvine	California
United States	Synergy Research Site	Jackson	Tennessee
United States	Synergy Research Site	Jacksonville	North Carolina
United States	Synergy Research Site.	Jacksonville	Florida
United States	Synergy Research Site	Kalamazoo	Michigan
United States	Synergy Research Site	Kettering	Ohio
United States	Synergy Research Site	Kew Gardens	New York
United States	Synergy Research Site	Kingsport	Tennessee
United States	Synergy Research Site	Kingwood	West Virginia
United States	Synergy Research Site	Knoxville	Tennessee
United States	Synergy Research Site	La Crosse	Wisconsin
United States	Synergy Research Site	Lampasas	Texas
United States	Synergy Research Site	Lansdale	Pennsylvania
United States	Synergy Research Site	Las Vegas	Nevada
United States	Synergy Research Site	Lauderdale Lakes	Florida
United States	Synergy Research Site	Levittown	Pennsylvania
United States	Synergy Research Site	Lilburn	Georgia
United States	Synergy Research Site	Little Rock	Arkansas
United States	Synergy Research Site	Lomita	California
United States	Synergy Research Site	Long Beach	California
United States	Synergy Research Site	Los Angeles	California
United States	Synergy Research Site	Madisonville	Kentucky
United States	Synergy Research Site	Maitland	Florida
United States	Synergy Research Site	Marietta	Georgia
United States	Synergy Research Site	Marlborough	Massachusetts
United States	Synergy Research Site	Marrero	Louisiana
United States	Synergy Research Site	McKinney	Texas
United States	Synergy Research Site	Mentor	Ohio
United States	Synergy Research Site	Meridian	Idaho
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami Lakes	Florida
United States	Synergy Research Site	Miami Lakes	Florida
United States	Synergy Research Site	Miami Springs	Florida
United States	Synergy Research Site	Middleburg Heights	Ohio
United States	Synergy Research Site	Mission Hills	California
United States	Synergy Research Site	Missoula	Montana
United States	Synergy Research Site	Missouri City	Texas
United States	Synergy Research Site	Montclair	California
United States	Synergy Research Site	Morton	Illinois
United States	Synergy Research Site	Mount Pleasant	South Carolina
United States	Synergy Research Site	Naples	Florida
United States	Synergy Research Site	New York	New York
United States	Synergy Research Site	Norfolk	Virginia
United States	Synergy Research Site	North Miami Beach	Florida
United States	Synergy Research Site	Northridge	California
United States	Synergy Research Site	Norwalk	California
United States	Synergy Research Site	Oak Lawn	Illinois
United States	Synergy Research Site	Oceanside	California
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Omaha	Nebraska
United States	Synergy Research Site	Orange	California
United States	Synergy Research Site	Orange Park	Florida
United States	Synergy Research Site	Orangevale	California
United States	Synergy Research Site	Orem	Utah
United States	Synergy Research Site	Orlando	Florida
United States	Synergy Research Site.	Orlando	Florida
United States	Synergy Research Site	Ormond Beach	Florida
United States	Synergy Research Site	Owensboro	Kentucky
United States	Synergy Research Site	Oxon Hill	Maryland
United States	Synergy Research Site	Pembroke Pines	Florida
United States	Synergy Research Site	Philadelphia	Pennsylvania
United States	Synergy Research Site	Phoenix	Arizona
United States	Synergy Research Site	Pinellas Park	Florida
United States	Synergy Research Site	Placentia	California
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Port Arthur	Texas
United States	Synergy Research Site	Port Gibson	Mississippi
United States	Synergy Research Site	Port Orange	Florida
United States	Synergy Research Site	Poughkeepsie	New York
United States	Synergy Research Site	Quincy	Massachusetts
United States	Synergy Research Site	Raleigh	North Carolina
United States	Synergy Research Site	Richmond	Virginia
United States	Synergy Research Site	Richmond	Virginia
United States	Synergy Research Site	Riverside	California
United States	Synergy Research Site	Saint Louis	Missouri
United States	Synergy Research Site	Saint Louis	Missouri
United States	Synergy Research Site	Salisbury	North Carolina
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	San Marino	California
United States	Synergy Research Site	Santa Ana	California
United States	Synergy Research Site	Saraland	Alabama
United States	Synergy Research Site	Schaumburg	Illinois
United States	Synergy Research Site	Sherman Oaks	California
United States	Synergy Research Site	Snellville	Georgia
United States	Synergy Research Site	Spokane	Washington
United States	Synergy Research Site	Sugar Land	Texas
United States	Synergy Research Site	Surprise	Arizona
United States	Synergy Research Site	Tamarac	Florida
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Towson	Maryland
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Vancouver	Washington
United States	Synergy Research Site	Vineland	New Jersey
United States	Synergy Research Site	Wadsworth	Ohio
United States	Synergy Research Site	West Valley City	Utah
United States	Synergy Research Site	Wichita	Kansas
United States	Synergy Research Site	Williston	Florida
United States	Synergy Research Site	Winston-Salem	North Carolina

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	Number of Overall Responders - ITT Population	An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.	12 weeks
Primary	Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks	An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.	12 Weeks
Primary	Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks	A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.	12 Weeks
Secondary	Number of Sustained Efficacy Responders	A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.	12 Weeks
Secondary	Change From Baseline in Stool Consistency	Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7: Separate hard lumps, like nuts (hard 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	Baseline and 12-Week
Secondary	Change From Baseline in Straining	Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).	Baseline and 12-Week
Secondary	Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement	Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.	Baseline and 12-Week
Secondary	Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication	A responder was any patient with a SBM within 24 hours after the first dose of study drug.	Up to 24 hours after the first dose of study drug
Secondary	Change From Baseline in Abdominal Pain	Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.	Baseline and 12-Week