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NCT02559206 · ClinicalTrials.gov registry record · Phase 2
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 2 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 759
- Enrollment target
NCT02559206: Completed Phase 2 study, sponsored by Ironwood Pharmaceuticals.
NCT02559206 is a Phase 2 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 759 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (471% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02559206, a Phase 2 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 759 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).
Primary Outcome
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Interventions
- DRUG Matching Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 759 participants |
| Start Date | 2015-10-22 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 2 |
What the finished NCT02559206 record still lists
NCT02559206 is an interventional study that assigns participants to a tested intervention. The registered 759 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (471% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT02559206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02559206 about?
NCT02559206 is a clinical study titled "Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)". The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objective...
What is the current status of trial NCT02559206?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 759 participants. The study started on 2015-10-22. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT02559206?
The interventions under investigation include: Matching Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT02559206?
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 NCT02559206's enrollment target sits among peer trials
759 43rd of 2000 higher than 1,958 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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