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NCT03573908 · ClinicalTrials.gov registry record · Phase 3
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 3 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
NCT03573908: Completed Phase 3 study, sponsored by Ironwood Pharmaceuticals.
NCT03573908 is a Phase 3 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 614 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03573908, a Phase 3 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
Study Summary
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
Primary Outcome
A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The participant's abdominal score was averaged on a weekly basis, and each we
Interventions
- DRUG Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2019-04-10 |
| Phase | Phase 3 |
What the finished NCT03573908 record still lists
NCT03573908 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03573908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03573908 about?
NCT03573908 is a clinical study titled "A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)". To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
What is the current status of trial NCT03573908?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2018-06-20. Estimated completion is 2019-04-10.
What interventions are being tested in trial NCT03573908?
The interventions under investigation include: Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT03573908?
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 NCT03573908's enrollment target sits among peer trials
614 593rd of 2000 higher than 1,403 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
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