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

NCT00546507 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2010-10-13

No results posted yet for this 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

Interventions

DRUG

TDS-943 (topical diclofenac sodium 4% spray)

DRUG

celecoxib

OTHER

placebo

Sponsors & Collaborators

  • Mika Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Affairs · Mika Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546507 on ClinicalTrials.gov