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NCT00609973 · ClinicalTrials.gov registry record · Phase 2
Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT00609973: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT00609973 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00609973, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
Despite extensive medical treatment, surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of patients and is a serious limitation of surgical management. Therapeutic options to maintain postoperative clinical remission are urgently needed. Several drugs including mesalazine, antibiotics (metronidazole, ornidazole) and azathioprine or 6-mercaptopurine have been studied in the past. But the efficacy is very limited (mesalazine), overshadowed by intolerability during long-term therapy (metronidazole, ornidazole) or inconclusive (azathioprine or 6-mercaptopurine). Research demonstrating the absence of inflammation in patients with diverting ileostomy and the clinical benefit of a postoperative antibiotic therapy using metronidazole or ornidazole implicates a role of the resident bacterial flora in the postoperative relapse. Ciprofloxacin has a broad antibacterial spectrum. More interestingly it also suppresses E. coli strains, which can be found in high numbers in early and chronic ileal lesions of Crohn's disease patients Ciprofloxacin has demonstrated beneficial effects in the therapy of inflammatory bowel diseases, but the available data of the effectiveness of ciprofloxacin allow only a very limited judgement of the safety and tolerability of a 6 months therapy of ciprofloxacin. Therefore an exploratory multicenter prospective, placebo-controlled trial is planned to analyze the safety and tolerability of a 6 months therapy with ciprofloxacin compared to placebo in 40 patients (randomly assigned in a 1:1 ratio) undergoing ileocecal resection (or resection of parts of the colon). If this therapeutic regimen demonstrates tolerability, a second larger study improving the superiority of ciprofloxacin versus placebo can be initiated.
Primary Outcome
Adverse events (AE) Discontinuation of study drug due to probably study drug related AE
Interventions
- DRUG Placebo
- DRUG Ciprofloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00609973 record still lists
NCT00609973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00609973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00609973 about?
NCT00609973 is a clinical study titled "Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease". Despite extensive medical treatment, surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of patients and is a serious limitation of surgical management. Therapeutic options to maintain postoperati...
What is the current status of trial NCT00609973?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2008-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00609973?
The interventions under investigation include: Placebo (DRUG), Ciprofloxacin (DRUG).
Who is sponsoring clinical trial NCT00609973?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00609973's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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