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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01722318
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : January 15, 2015
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Characterized by Constipation Drug: Plecanatide Drug: Placebo Phase 2

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 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, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide

Arm Intervention/treatment
Active Comparator: Plecanatide 0.3mg
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Active Comparator: Plecanatide 1.0mg
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Active Comparator: Plecanatide 3.0mg
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Active Comparator: Plecanatide 9.0mg
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Placebo Comparator: Placebo
Placebo, one tablet by mouth daily for 12 weeks
Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in the mean number of Complete Spontaneous Bowel Movement (CSBM) over the 12 week treatment period [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients who are overall responders during the 12 week Treatment period [ Time Frame: 12 weeks ]
    Abdominal pain intensity and stool frequency are co-endpoints for the responder analysis. A patient is categorized as a weekly responder on both pain intensity and stool frequency.

Other Outcome Measures:
  1. Other secondary endpoints [ Time Frame: 12 weeks ]
    Change from baseline in Spontaneous Bowel Movement (SBM) frequency, stool consistency (BSFS), time to first SBM/CSBM, patient IVRS reported symptoms,and patient questionnaires ( QoL, Irritable Bowel Syndrome Severity Score (IBSSS), global severity, relief and treatment assessment) over the 12 week treatment period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01722318

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Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Principal Investigator: Philip B Miner, MD Oklahoma Foundation for Digestive Research

Responsible Party: Synergy Pharmaceuticals Inc. Identifier: NCT01722318     History of Changes
Other Study ID Numbers: SP304-20212
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

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