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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 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.

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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

Sponsor

Mika Pharma

2 total trials

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What the Registry Record Tells You About NCT00546507

The ClinicalTrials.gov registry entry for NCT00546507 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 650 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 813-participant average among 135 other Osteoarthritis trials with a reported enrollment target (20% lower). The listed sponsor is Mika Pharma, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.