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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 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 15 participants.
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.
Interventions
- DRUG duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00401258
The ClinicalTrials.gov registry entry for NCT00401258 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which duloxetine is the first listed.
NCT00401258 reports 0 study locations.
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.
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