NCT00171678

Brief Summary

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

September 13, 2005

Last Update Submit

April 20, 2012

Conditions

Osteearthritis

Keywords

Knee osteoarthritis, Topical NSAID, Diclofenac sodium

Outcome Measures

Primary Outcomes (3)

  • WOMAC pain score in target knee at Week 12

  • WOMAC physical function score in target knee at Week 12

  • Global rating of disease activity by patient at Week 12

Secondary Outcomes (5)

  • WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8

  • WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12

  • Pain on movement in target knee and use of rescue medication recorded in diary

  • Global evaluation of treatment at final visit

  • Treatment responder rate according to OARSI criteria

Interventions

Diclofenac Topical Sodium Gel 1%DRUG

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Other rheumatic disease, such as rheumatoid arthritis
  • Active gastrointestinal ulcer during the last year
  • Known allergy to analgesic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Consumer Health Inc.

Parsippany, New Jersey, United States

Location

Related Publications (1)

  • Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.

    PMID: 21174485DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

April 23, 2012

Record last verified: 2012-04

Locations

US(1)