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NCT00546507 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I

A Phase 3 study of Osteoarthritis, sponsored by Mika Pharma.

Completed
Registry status
Phase 3
Development phase
650
Enrollment target
20
Study locations

NCT00546507: Completed Phase 3 study of Osteoarthritis, sponsored by Mika Pharma.

NCT00546507 is a Phase 3 study of Osteoarthritis that has completed, run by Mika Pharma. The registered enrollment target is 650 participants, below the 813-participant average among 135 other Osteoarthritis trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00546507, a Phase 3 study of Osteoarthritis, has completed, sponsored by Mika Pharma.

COMPLETED
Registry status
Phase 3
Development phase
650 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Osteoarthritis

Interventions

  • OTHER placebo
  • DRUG celecoxib
  • DRUG TDS-943 (topical diclofenac sodium 4% spray)

Study Locations (20)

Florida

  • - DeLand
  • - Jacksonville
  • - Kissimmee
  • - Ocala
  • - Ormond Beach
  • - Pembroke Pines
  • - Pinellas Park
  • - Stuart
  • - Tampa
  • - Tampa

California

  • - Fair Oaks
  • - Pico Rivera
  • - Santa Barbara
  • - Torrance

Arizona

  • - Mesa
  • - Tucson
  • - Tucson

Alabama

  • - Huntsville
  • - Mobile

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 650 participants
Start Date 2007-10
Est. Completion 2008-10
Phase Phase 3
Mika Pharma

2 total trials

What the finished NCT00546507 record still lists

NCT00546507 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 813-participant average among 135 other Osteoarthritis trials with a reported enrollment target (20% lower).

The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.

NCT00546507 names 20 study sites across 5 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT00546507 about?

NCT00546507 is a clinical study titled "Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I". 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 NCT00546507?

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 2008-10.

What conditions does trial NCT00546507 study?

This clinical trial studies the following conditions: Osteoarthritis.

What interventions are being tested in trial NCT00546507?

The interventions under investigation include: placebo (OTHER), celecoxib (DRUG), TDS-943 (topical diclofenac sodium 4% spray) (DRUG).

Who is sponsoring clinical trial NCT00546507?

This trial is sponsored by Mika Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00546507 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00546507's enrollment target sits among peer trials

650 21st of 135 higher than 115 of 135 other Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis 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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Related registry views

Source: ClinicalTrials.gov NCT00546507, the US trial registry maintained by the National Library of Medicine. NCT00546507 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.