Gastroenterology · Phase 3
Plecanatide: second 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 2026-09-20
Durable responder rates were 20.1% and 20.0% versus 12.8%. Diarrhea occurred in 3.2% and 4.5% versus 1.3%.↗
Keep in context: The registry reports 1,410 randomizations and an intention-to-treat population of 1,337 after excluding repeat enrollments. The closer-reading notes explain which populations support efficacy and safety results. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Participant counts describe different groups
The full text reports 1,410 randomizations, 1,402 treated participants in the safety population and 1,337 unique patients in the intention-to-treat analysis. The abstract’s group counts sum to the analysis population. Those denominators should not be interchanged. Full text ↗ · Indexed abstract ↗
Sections: Statistical analysis; Results.
A sustained response, not a single improved week
The primary responder definition required at least three complete spontaneous bowel movements in a week, with at least one more than baseline, in nine of twelve treatment weeks including three of the final four. Weeks with fewer than four complete diary days counted as nonresponse. Full text ↗ · Indexed abstract ↗
Sections: Efficacy; Statistical analysis.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 1,410 · 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 2019-05-28; 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: second phase 3 trial
- Design in the report
- Randomized, double-blind, placebo-controlled 12-week trial.↗
- Participants in the report
- The abstract reports groups totaling 1,337 adults with chronic idiopathic constipation.↗
- Limitations
- This is a separate trial from the first constipation report. Patient diaries and the defined responder threshold need full-report appraisal.↗
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 National CIC3 Study) ↗
Protocol identifier: SP304203-03. Sponsor: Bausch Health Americas, Inc..
Retrieved 2026-09-20; SHA-256 3d90f63d75dfa45322c6c91fb4f0485324e41837e253c24c527a9a6e5cbc96b8.
PMID 29147135
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 29147135. SHA-256 26cf34ec94efdddd9e1b4586101cbd99f74123b951080a793a0bf4ad6d606357.
Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 26cf34ec94efdddd9e1b4586101cbd99f74123b951080a793a0bf4ad6d606357.
Selected full text: PMC5673020
Retrieved 2026-09-20; SHA-256 d6571ec3c539f7bdcacbd6f5e981e25851c7083e204cfccca3818e1fc5be3701. Section identifiers and hashes are included in the cited study data.