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

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ClinicalTrials.gov Identifier: NCT02493452
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE June 23, 2015
First Posted Date  ICMJE July 9, 2015
Results First Submitted Date  ICMJE May 23, 2019
Results First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Study Start Date  ICMJE June 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Number of Overall Responders - ITT Population [ Time Frame: 12 weeks ]
    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.
  • Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks [ Time Frame: 12 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.
  • Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks [ Time Frame: 12 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • The primary efficacy endpoint is Overall Responder [ Time Frame: 12 weeks ]
    An Overall Responder* is a patient who is a weekly responder (i.e., meets both the abdominal pain intensity and stool frequency responder criteria in the same week) for at least 6 of the 12 treatment weeks.
  • Abdominal Pain Intensity Weekly Responder [ Time Frame: 12 Weeks ]
    An Abdominal Pain Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30 percent compared with baseline weekly average.
  • Stool Frequency Responder [ Time Frame: 12 Weeks ]
    A Stool Frequency Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Number of Sustained Efficacy Responders [ Time Frame: 12 Weeks ]
    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.
  • Change From Baseline in Stool Consistency [ Time Frame: Baseline and 12-Week ]
    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:
    1. Separate hard lumps, like nuts (hard to pass)
    2. Sausage-shaped but lumpy
    3. Like a sausage but with cracks on its surface
    4. Like a sausage or snake, smooth and soft
    5. Soft blobs with clear-cut edges (passed easily)
    6. Fluffy pieces with ragged edges, a mushy stool
    7. Watery, no solid pieces, entirely liquid
  • Change From Baseline in Straining [ Time Frame: Baseline and 12-Week ]
    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).
  • Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement [ Time Frame: Baseline and 12-Week ]
    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.
  • Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication [ Time Frame: Up to 24 hours after the first dose of study drug ]
    A responder was any patient with a SBM within 24 hours after the first dose of study drug.
  • Change From Baseline in Abdominal Pain [ Time Frame: Baseline and 12-Week ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • Complete Spontaneous Bowel Movement [ Time Frame: 12 Weeks ]
    Change from baseline in CSBM Frequency Rate ( numeric counts )
  • Spontaneous Bowel Movement [ Time Frame: 12 Weeks ]
    Change from baseline in SBM Frequency Rate ( numeric counts )
  • Stool Consistency based upon the Bristol Stool Form Scale [ Time Frame: 12 Weeks ]
    Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7
  • Sustained Efficacy Responder [ Time Frame: 12 Weeks ]
    Overall Response in the last 4 weeks of the 12 weeks treatment period
  • Time to first SBM and CSBM [ Time Frame: 12 Weeks ]
    Time to first SBM and CSBM as measured after first dose of treatment
  • Change and Percent Change from baseline in abdominal pain [ Time Frame: 12 Weeks ]
    Change and Percent Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale
  • Stool Frequency Responder for at least 6 of the 12 treatment weeks [ Time Frame: 12 Weeks ]
    Stool Frequency Responder for at least 6 of the 12 treatment weeks ( numeric count of week )
  • Time to first use of Rescue Medication (RM) [ Time Frame: 12 Weeks ]
    Time to first use of Rescue Medication (RM) after first dose of treatment
  • Overall Responder for at least 9 of the 12 treatment weeks [ Time Frame: 12 Weeks ]
    Overall Responder for at least 9 of the 12 treatment weeks (meets both the abdominal pain intensity and stool frequency responder criteria in the same week )
  • SBMs and CSBMs within 24 hours after first dose of study medication [ Time Frame: 12 Weeks ]
    SBMs and CSBMs within 24 hours after first dose of study medication (numeric counts )
  • Symptoms associated with IBS-C [ Time Frame: 12 Weeks ]
    Change from baseline in other symptoms associated with IBS-C (abdominal bloating, abdominal discomfort, abdominal cramping, straining with a bowel movement and sensation of incomplete evacuation) all measured on a 11 point scale
  • Patient Global Questionnaires [ Time Frame: 12 Weeks ]
    Patient Global Questionnaires (IBS Disease Severity, IBS-Quality of Life, Patient Rating of Relief of IBS Symptoms, Patient Rating of Relief of Abdominal Pain, Treatment Continuation and Treatment Satisfaction Assessments ) all measured on a 5 point scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
Official Title  ICMJE 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)
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome Characterized by Constipation
Intervention  ICMJE
  • Drug: Plecanatide
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: 3.0 mg plecanatide
    Plecanatide 3.0 mg dosed daily for 12 weeks
    Intervention: Drug: Plecanatide
  • Active Comparator: 6.0 mg plecanatide
    Plecanatide 6.0 mg dosed daily for 12 weeks
    Intervention: Drug: Plecanatide
  • Active Comparator: Matching placebo
    Placebo dosed daily for 12 weeks
    Intervention: Drug: Placebo
Publications * Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2019)
1135
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2015)
1050
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02493452
Other Study ID Numbers  ICMJE SP304203-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul F.C. Eng, PhD Synergy Pharmaceuticals Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP