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NCT00975143 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne
A Phase 3 study, sponsored by Cipher Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 925
- Enrollment target
NCT00975143: Completed Phase 3 study, sponsored by Cipher Pharmaceuticals.
NCT00975143 is a Phase 3 study that has completed, run by Cipher Pharmaceuticals. The registered enrollment target is 925 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00975143, a Phase 3 study, has completed, sponsored by Cipher Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 925 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.
Primary Outcome
The change from Baseline to Week 20 in the total number of nodular lesions was calculated as the Week 20 lesion count minus Baseline lesion count and compared using Analysis of Covariance (ANCOVA), controlling for Baseline total nodular lesion count, gender and analysis site. The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was also calculated using the ANCOVA model. Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatm
Interventions
- DRUG Isotretinoin
- DRUG CIP-Isotretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 925 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00975143 record still lists
NCT00975143 is an interventional study that assigns participants to a tested intervention. The registered 925 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Isotretinoin is the first listed.
NCT00975143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00975143 about?
NCT00975143 is a clinical study titled "Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne". The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.
What is the current status of trial NCT00975143?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 925 participants. The study started on 2009-09. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00975143?
The interventions under investigation include: Isotretinoin (DRUG), CIP-Isotretinoin (DRUG).
Who is sponsoring clinical trial NCT00975143?
This trial is sponsored by Cipher Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00975143's enrollment target sits among peer trials
925 341st of 2000 higher than 1,659 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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