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NCT01641341 · ClinicalTrials.gov registry record · Phase 4
Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
A Phase 4 study, sponsored by American Academy of Family Physicians.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT01641341: Completed Phase 4 study, sponsored by American Academy of Family Physicians.
NCT01641341 is a Phase 4 study that has completed, run by American Academy of Family Physicians. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641341, a Phase 4 study, has completed, sponsored by American Academy of Family Physicians.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study Summary
Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Patient outcome data will provide a more precise estimate of power for a larger, classic randomized trial to determine if such a study can be reasonably undertaken within primary care practices. Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics (GDx) test on treatment, and 3) observe and track patients' health, quality of life and clinical outcomes related to IBS during the study period.
Primary Outcome
20 to 40% of the control/placebo patients and approximately 70-75% of the treatment patients will experience a positive outcome as determined by both the daily log sheets and the modified Rome criteria administered at baseline, 8 and 16 weeks.
Interventions
- DRUG Placebo
- DRUG Pancrelipase
- DRUG Nitazoxanide
- DRUG Bifidobacterium infantis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
What the finished NCT01641341 record still lists
NCT01641341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01641341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01641341 about?
NCT01641341 is a clinical study titled "Irritable Bowel Syndrome Evaluation and Treatment in Primary Care". Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in prima...
What is the current status of trial NCT01641341?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2010-11. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01641341?
The interventions under investigation include: Placebo (DRUG), Pancrelipase (DRUG), Nitazoxanide (DRUG), Bifidobacterium infantis (DRUG).
Who is sponsoring clinical trial NCT01641341?
This trial is sponsored by American Academy of Family Physicians, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01641341's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 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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