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NCT02263365 · ClinicalTrials.gov registry record · Phase 3
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
A Phase 3 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT02263365: Clinical Trial Phase 3 study, sponsored by Cedars-Sinai Medical Center.
NCT02263365 is a Phase 3 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02263365, a Phase 3 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may potentially have a delay in the adjuvant therapy when faced with this complication. Studies performed in this groups of patients report a readmission rate of 17-21% for dehydration. Loperamide has been shown to significantly decrease the daily volume of weight of stool in these patients. The purpose of this study is to establish whether loperamide given at 4mg three times daily for 14 days from day of discharge empirically decreases 30 days readmission rate for dehydration. The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the readmission rates, that severity of dehydration will be decreased.
Interventions
- DRUG Loperamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10-07 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 3 |
Why NCT02263365 stopped before completion
NCT02263365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Loperamide is the first listed.
NCT02263365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02263365 about?
NCT02263365 is a clinical study titled "Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies". Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes...
What is the current status of trial NCT02263365?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2014-10-07. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT02263365?
The interventions under investigation include: Loperamide (DRUG).
Who is sponsoring clinical trial NCT02263365?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02263365's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 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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