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NCT00546832 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
A Phase 3 study, sponsored by Mika Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 650
- Enrollment target
NCT00546832: Completed Phase 3 study, sponsored by Mika Pharma.
NCT00546832 is a Phase 3 study that has completed, run by Mika Pharma. The registered enrollment target is 650 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546832, a Phase 3 study, has completed, sponsored by Mika Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 650 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.
Interventions
- OTHER placebo
- DRUG celecoxib
- DRUG TDS-943 (topical diclofenac sodium 4% spray)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
What the finished NCT00546832 record still lists
NCT00546832 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00546832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00546832 about?
NCT00546832 is a clinical study titled "Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II". The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.
What is the current status of trial NCT00546832?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 650 participants. The study started on 2007-10. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00546832?
The interventions under investigation include: placebo (OTHER), celecoxib (DRUG), TDS-943 (topical diclofenac sodium 4% spray) (DRUG).
Who is sponsoring clinical trial NCT00546832?
This trial is sponsored by Mika Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00546832's enrollment target sits among peer trials
650 572nd of 2000 higher than 1,429 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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