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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 is a Phase 4 study that has completed, run by American Academy of Family Physicians. The registered enrollment target is 61 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641341
The ClinicalTrials.gov registry entry for NCT01641341 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Academy of Family Physicians, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01641341 reports 0 study locations.
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.
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