Three selected publications report four randomized phase 3 trials in adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.123
Bottom line from this bounded source set
The trials found more participants met prespecified bowel-response endpoints with plecanatide than placebo. Diarrhea occurred more often with active treatment; these 12-week studies do not establish comparative superiority to other medicines.123
Reviewed study record
Chronic idiopathic constipation: first phase 3 trial
Design
Randomized, double-blind, placebo-controlled trial over 12 weeks with two active groups.1
Population
1,394 adults with chronic idiopathic constipation were randomized.1
Outcomes reported
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%.1
Limitations
The endpoint combines frequency and persistence of response. Results concern the enrolled adults and short follow-up, not all constipation causes.1
Reviewed study record
Chronic idiopathic constipation: second phase 3 trial
1,337 adults were allocated across two active groups and placebo.2
Outcomes reported
Durable responder rates were 20.1% and 20.0% versus 12.8%. Diarrhea occurred in 3.2% and 4.5% versus 1.3%.2
Limitations
This is a separate trial from the first constipation report. Patient diaries and the defined responder threshold need full-report appraisal.2
Reviewed study record
Irritable bowel syndrome with constipation: two trials
Design
Two randomized, double-blind, placebo-controlled phase 3 trials over 12 weeks.3
Population
2,189 adults were randomized across both trials; 1,879 completed.3
Outcomes reported
Combined pain-and-bowel response was more frequent in active groups in each trial. Diarrhea occurred in about 4% of active-group participants versus 1% with placebo and sometimes led to withdrawal.3
Limitations
The publication contains two studies and uses an endpoint different from the chronic-constipation trials. Cross-trial response percentages are not treatment rankings.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/ajg.2016.611. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1177/1756283x17734697. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/s41395-018-0026-7. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗