NCT00650624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

First QC Date

March 31, 2008

Last Update Submit

December 7, 2018

Conditions

Osteoarthritis, Knee

Keywords

knee osteoarthritis; Japan

Outcome Measures

Primary Outcomes (1)

  • WOMAC (Western Ontario and McMaster Universities) OA Pain Index

    screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)

Secondary Outcomes (7)

  • patients' and physicians' and 'categorical' global assessment of arthritis

    screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

  • WOMAC OA stiffness index

    screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

  • WOMAC OA physical function index

    screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

  • WOMAC OA composite index

    screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

  • WOMAC OA pain index, stiffness index, physical function index, and composite index

    screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

  • +2 more secondary outcomes

Study Arms (4)

Arm 1

ACTIVE COMPARATOR
Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR
Drug: valdecoxib

Arm 3

ACTIVE COMPARATOR
Drug: valdecoxib

Arm 4

PLACEBO COMPARATOR
Drug: placebo

Interventions

valdecoxibDRUG

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

Arm 1
placeboDRUG

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

Arm 4

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
  • At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's \& Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"

You may not qualify if:

  • Patients unable to walk generally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

Funabashi, Chiba, Japan

Location

Pfizer Investigational Site

Sakura, Chiba, Japan

Location

Pfizer Investigational Site

Chikushi-gun, Fukuoka, Japan

Location

Pfizer Investigational Site

Iizuka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kurume, Fukuoka, Japan

Location

Pfizer Investigational Site

Yame, Fukuoka, Japan

Location

Pfizer Investigational Site

Chitose, Hokkaido, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Kamakura, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Isahaya, Nagasaki, Japan

Location

Pfizer Investigational Site

Hirakata, Osaka, Japan

Location

Pfizer Investigational Site

Kanzaki-gun, Saga-ken, Japan

Location

Pfizer Investigational Site

Karatsu, Saga-ken, Japan

Location

Pfizer Investigational Site

Ogi-gun, Saga-ken, Japan

Location

Pfizer Investigational Site

Itabashi-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Taito-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Yoyogi Shibuya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Saga, Japan

Location

Pfizer Investigational Site

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 2, 2008

Study Start

June 1, 2003

Study Completion

January 1, 2004

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

JP(22)