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NCT00401258 · ClinicalTrials.gov registry record · Phase 4
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
A Phase 4 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00401258: Completed Phase 4 study, sponsored by Mclean Hospital.
NCT00401258 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00401258, a Phase 4 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder. During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be treated with open-label duloxetine.
Primary Outcome
Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.
Interventions
- DRUG duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00401258 record still lists
NCT00401258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which duloxetine is the first listed.
NCT00401258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00401258 about?
NCT00401258 is a clinical study titled "An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome". We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder. During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years wh...
What is the current status of trial NCT00401258?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2006-11. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00401258?
The interventions under investigation include: duloxetine (DRUG).
Who is sponsoring clinical trial NCT00401258?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00401258's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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