Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02291679 · ClinicalTrials.gov registry record · Phase 3
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
A Phase 3 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,223
- Enrollment target
NCT02291679: Completed Phase 3 study, sponsored by Ironwood Pharmaceuticals.
NCT02291679 is a Phase 3 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 1,223 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02291679, a Phase 3 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,223 participants
- Enrollment target
Study Summary
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
Primary Outcome
A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative,
Interventions
- DRUG Matching Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,223 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT02291679 record still lists
NCT02291679 is an interventional study that assigns participants to a tested intervention. Its 1,223 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT02291679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02291679 about?
NCT02291679 is a clinical study titled "Trial of Linaclotide in Patients With Chronic Idiopathic Constipation". The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for comple...
What is the current status of trial NCT02291679?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,223 participants. The study started on 2014-10. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02291679?
The interventions under investigation include: Matching Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT02291679?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02291679's enrollment target sits among peer trials
1,223 214th of 2000 higher than 1,787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06921785 · 1,220 participants · Phase 3
Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
- NCT06143956 · 1,217 participants · Phase 2
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
- NCT05946044 · 1,230 participants · NA
The Osteoarthritis Prevention Study
- NCT06787937 · 1,230 participants · NA
Communicating About Nicotine Reduction in Cigarettes
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia