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

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ClinicalTrials.gov Identifier: NCT02387359
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Characterized by Constipation Drug: Plecanatide Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 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)
Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide

Arm Intervention/treatment
Active Comparator: 3.0 mg plecanatide
Plecanatide 3.0 mg dosed daily for 12 weeks
Drug: Plecanatide
Active Comparator: 6.0 mg plecanatide
Plecanatide 6.0 mg dosed daily for 12 weeks
Drug: Plecanatide
Active Comparator: Matching placebo
Placebo dosed daily for 12 weeks
Drug: Placebo



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Complete Spontaneous Bowel Movement [ Time Frame: 12 weeks ]
    Change from baseline in CSBM Frequency Rate ( numeric counts )

  2. Spontaneous Bowel Movement [ Time Frame: 12 weeks ]
    Change from baseline in SBM Frequency Rate ( numeric counts )

  3. 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

  4. Sustained Efficacy Responder [ Time Frame: 12 weeks ]
    Overall Response in the last 4 weeks of the 12 weeks treatment period

  5. Time to first SBM and CSBM [ Time Frame: 12 weeks ]
    Time to first SBM and CSBM as measured after first dose of treatment

  6. 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

  7. 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 )

  8. 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

  9. 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 )

  10. 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 )

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 > 35 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387359


  Show 145 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Investigators
Study Director: Paul F.C. Eng, PhD Synergy Pharmaceuticals Inc.

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02387359     History of Changes
Other Study ID Numbers: SP304203-04
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Intestinal Diseases
Plecanatide
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Agents