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NCT00231153 · ClinicalTrials.gov registry record · Phase 3
Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
A Phase 3 study, sponsored by Cadence Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,859
- Enrollment target
NCT00231153: Completed Phase 3 study, sponsored by Cadence Pharmaceuticals.
NCT00231153 is a Phase 3 study that has completed, run by Cadence Pharmaceuticals. The registered enrollment target is 1,859 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231153, a Phase 3 study, has completed, sponsored by Cadence Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,859 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
Primary Outcome
LCSI was defined as a study catheter showing any 2 of the following criteria: erythema \>= 2; edema \>= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.
Interventions
- DRUG Povidone-Iodine 10%
- DRUG Omiganan 1% gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,859 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00231153 record still lists
NCT00231153 is an interventional study that assigns participants to a tested intervention. Its 1,859 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 2 interventions - of which Povidone-Iodine 10% is the first listed.
NCT00231153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00231153 about?
NCT00231153 is a clinical study titled "Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters". The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
What is the current status of trial NCT00231153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,859 participants. The study started on 2005-08. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00231153?
The interventions under investigation include: Povidone-Iodine 10% (DRUG), Omiganan 1% gel (DRUG).
Who is sponsoring clinical trial NCT00231153?
This trial is sponsored by Cadence Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00231153's enrollment target sits among peer trials
1,859 114th of 2000 higher than 1,887 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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