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A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)

NCT00650624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2018-12-11

No results posted yet for this study

Summary

To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis of the knee.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

valdecoxib

valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks

DRUG

valdecoxib

valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks

DRUG

valdecoxib

valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks

DRUG

placebo

placebo tablet by mouth once daily in the morning for 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Completion
2004-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00650624 on ClinicalTrials.gov