Phase 2
N=428
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Irritable Bowel Syndrome Characterized by Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01722318 ↗Enrolled (actual)
428
Serious AEs
0.9%
Results posted
Sep 2018
Primary outcome: Primary: Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population) — 1.28; 2.12; 2.74; 2.44 CSBMs per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plecanatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population) |
1.28; 2.12; 2.74; 2.44; 1.27 | — |
| SECONDARY Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population) |
-1.5; -1.5; -2.0; -1.8; -1.4 | — |
| SECONDARY Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population) |
1.63; 1.81; 2.49; 2.24; 1.01 | — |
| SECONDARY Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population) |
-1.7; -1.5; -2.2; -2.1; -1.3 | — |
Summary
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01722318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.