Phase 3
N=1,337
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
Chronic Idiopathic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02122471 ↗Enrolled (actual)
1,337
Serious AEs
1.4%
Results posted
Mar 2019
Primary outcome: Primary: Number of Durable Overall CSBM Responders, Mean Replacement Approach — 57; 88; 88 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Plecanatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Durable Overall CSBM Responders, Mean Replacement Approach |
57; 88; 88 | — |
| SECONDARY Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach |
1.41; 2.34; 2.19; 1.69; 2.66; 2.50 | — |
| SECONDARY Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach |
1.55; 1.79; 1.63; 1.81; 3.25; 3.10 | — |
| SECONDARY Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach |
2.35; 2.16; 2.27; 1.02; 1.71; 1.59 | — |
| SECONDARY Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach |
2.42; 2.46; 2.47; -0.79; -1.09; -1.04 | — |
Summary
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18-80, inclusive
- Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
- Completed a colonoscopy in accordance with American Gastroenterological Association (AGA) colon cancer screening guidelines (5 years), with no clinically significant findings
- Willing to maintain a stable diet during 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 Bowel Movements (BMs) during the 3 months prior to screening visit OR during the 14 day pre-treatment assessment
- Active peptic ulcer disease, diabetes or hypertension 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, stroke or myocardial infarction (MI) within 60 days of screening
- Participated in a previous plecanatide clinical trial
Data sourced from ClinicalTrials.gov (NCT02122471). 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.