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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01722318
First received: November 2, 2012
Last updated: January 14, 2014
Last verified: January 2014

November 2, 2012
January 14, 2014
November 2012
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01722318 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Other secondary endpoints [ Time Frame: 12 week ] [ Designated as safety issue: No ]
Spontaneous Bowel Movement (SBM) frequency, stool consistency (BSFS), time to first SBM/CSBM, patient IVRS reported symptoms,patient questionnaires ( QoL, Irritable Bowel Syndrome Severity Score (IBSSS), global severity, relief and treatment assessment)
 
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
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)

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

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome Characterized by Constipation
  • Drug: Plecanatide
  • Drug: Placebo
  • Active Comparator: Plecanatide 0.3mg
    Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
    Intervention: Drug: Plecanatide
  • Active Comparator: Plecanatide 1.0mg
    Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
    Intervention: Drug: Plecanatide
  • Active Comparator: Plecanatide 3.0mg
    Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
    Intervention: Drug: Plecanatide
  • Active Comparator: Plecanatide 9.0mg
    Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
    Intervention: Drug: Plecanatide
  • Placebo Comparator: Placebo
    Placebo, one tablet by mouth daily for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
April 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01722318
SP304-20212
No
Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals Inc.
Not Provided
Principal Investigator: Philip B Miner, MD Oklahoma Foundation for Digestive Research
Synergy Pharmaceuticals Inc.
January 2014

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