NCT00171691

Brief Summary

This study will test the efficacy and safety of topical Voltaren 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
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

April 20, 2012

Conditions

Osteoarthritis

Keywords

Knee osteoarthritis, Topical NSAID, Diclofenac sodium

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment-emergent adverse events

  • Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary Outcomes (3)

  • Incidence of serious treatment-emergent adverse events

  • Number of patients who discontinued study medication due to a treatment-emergent adverse event

  • WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

Interventions

Diclofenac Topical Sodium Gel 1%DRUG

Eligibility Criteria

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

You may qualify if:

  • Osteoarthritis of the knee

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)

  • Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011 Sep;39(3):31-8. doi: 10.3810/psm.2011.09.1918.

    PMID: 22030938DERIVED

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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

June 1, 2006

Study Completion

June 1, 2006

Last Updated

April 23, 2012

Record last verified: 2012-04

Locations

US(1)