Gastroenterology · Phase 3
Plecanatide: first pivotal constipation trial
What was tested?
Plecanatide versus placebo in adults with chronic idiopathic constipation. ↗
Registered primary question: A sustained complete spontaneous bowel-movement response over 12 treatment weeks. ↗
What the reviewed report found
Journal year 2017 · Article summary reviewed 2026-09-15
Durable bowel-response rates were 21.0% and 19.5% in active groups versus 10.2% with placebo. Diarrhea occurred in 5.9% and 5.7% versus 1.3%.↗
Keep in context: The registry distinguishes 1,394 randomizations from 1,346 unique patients in the intention-to-treat population, after excluding repeat enrollments. The abstract’s randomized count is not the efficacy-analysis denominator. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 1,394 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years to 80 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2019-12-26; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Chronic idiopathic constipation: first phase 3 trial
- Design in the report
- Randomized, double-blind, placebo-controlled trial over 12 weeks with two active groups.↗
- Participants in the report
- 1,394 adults with chronic idiopathic constipation were randomized.↗
- Limitations
- The endpoint combines frequency and persistence of response. Results concern the enrolled adults and short follow-up, not all constipation causes.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
12-Week Study of Plecanatide for CIC (The CIC3 Study) ↗
Protocol identifier: SP304203-00. Sponsor: Bausch Health Americas, Inc..
Retrieved 2026-09-20; SHA-256 3f56b9edd18ab49f3dcb92da8d278d0667350c6d8deb81bb0c3f3323fa6f8dcf.
PMID 28169285
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch XML; locate MedlineCitation/PMID 28169285. SHA-256 fb1a08d480ff886b0af95cffce18d0803cd62d98d4609187165d4ca9cd7a7689.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 fb1a08d480ff886b0af95cffce18d0803cd62d98d4609187165d4ca9cd7a7689.