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

This study is currently recruiting participants.
Verified May 2013 by Synergy Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Synergy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01722318
First received: November 2, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome Characterized by Constipation
 Drug: Plecanatide
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Synergy Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from baseline in the mean number of Complete Spontaneous Bowel Movement (CSBM) over the 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who are overall responders during the 12 week Treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Other secondary endpoints [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 350
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722318

Contacts
Contact: Laura Barrow, Pharm D 212 297 0020 lbarrow@synergypharma.com

  Show 68 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals, Inc.
Investigators
Principal Investigator: Philip B Miner, MD Oklahoma Foundation for Digestive Research
  More Information

Additional Information:
Patients interested in trial participation are instructed to visit the CIBS website for prescreening and identification of an investigative site in the area.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Synergy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01722318     History of Changes
Other Study ID Numbers: SP304-20212
Study First Received: November 2, 2012
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013