Phase 3
N=951
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Chronic Idiopathic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01429987 ↗Enrolled (actual)
951
Serious AEs
1.0%
Results posted
Nov 2017
Primary outcome: Primary: Overall Responder 9/12 Weeks — 18.6; 16.8; 19.0; 10.7 % of Overall Responder 9/12 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- plecanatide (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Responder 9/12 Weeks |
18.6; 16.8; 19.0; 10.7 | — |
| SECONDARY Change From Baseline in 12-week CSBM Weekly Frequency Rate |
1.60; 1.81; 2.18; 1.09 | — |
| SECONDARY Change From Baseline in 12-week SBM Weekly Frequency Rate |
2.20; 2.38; 3.00; 1.35 | — |
| SECONDARY Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period |
1.28; 1.70; 1.97; 0.87 | — |
| SECONDARY Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score |
-1.25; -1.46; -1.73; -1.04 | — |
Summary
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
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 functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
- Less than 3 CSBMs per week at baseline and during pretreatment
- Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
- 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 (Bristol score- 6 or 7) 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 treatment period
- Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
- 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: diseases or conditions associated with constipation (GI or CNS), 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 (NCT01429987). 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.