Clinical trial NCT00171665: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Official title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Hand osteoarthritis, Topical NSAID, Diclofenac sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.


Eligibility criteria: Key Inclusion criteria:

• Osteoarthritis of the hand

Key Exclusion Criteria:

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

Primary outcomes:
measure: OA pain intensity in target hand at Week 4 and 6
measure: Total AUSCAN score in target hand at Week 4 and 6
measure: Global rating of disease activity by patient at Week 4 and 6
Secondary outcomes:
measure: OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
measure: AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8
measure: OA pain intensity in target hand and use of rescue medication recorded in diary
measure: Global evaluation of treatment at final visit
measure: Treatment responder rate according to OARSI criteria
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Calera
country: United States
facility: MedSearch, LLC
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Rheumatology Associates
state: Alabama
city: Montgomery
country: United States
facility: Drug Research & Analysis Corp
state: Alabama
city: Glendale
country: United States
facility: Arizona Center for Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical Research Center, LLC
state: Arizona
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Carmichael
country: United States
facility: Med Investigations/Med Center
state: California
city: Santa Barbara
country: United States
facility: H. Richard Barthel,MD, Inc.
state: California
city: Danbury
country: United States
facility: Clinical Research of CT/NY
state: Connecticut
city: Hamden
country: United States
facility: Allergy and Arthritis Associates
state: Connecticut
city: Hamden
country: United States
facility: Arthritis & Osteoporosis Center, PC
state: Connecticut
city: Stratford
country: United States
facility: Clinical Research Consultants
state: Connecticut
city: Newark
country: United States
facility: Health Core
state: Delaware
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, DO PA
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research
state: Florida
city: Sarasota
country: United States
facility: University Neurology
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: Radiant Research - Atlanta West
state: Georgia
city: Boise
country: United States
facility: Intermountain Orthopaedics
state: Idaho
city: Arlington Heights
country: United States
facility: Allan B. Aven, MD, SC
state: Illinois
city: Arkansas City
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Baltimore
country: United States
facility: Chesapeake Medical Research, LLC
state: Maryland
city: Peabody
country: United States
facility: Arthritis Associates, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinsite
state: Michigan
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Edina
country: United States
facility: Radiant Research - Minneapolis
state: Minnesota
city: Florissant
country: United States
facility: PrimeCare Research Associates
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Turnersville
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Winston Salem
country: United States
facility: Carolina Clinical Research
state: North Carolina
city: Kettering
country: United States
facility: Wells Institute for Heatlh Awareness
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source
state: Ohio
city: Eugene
country: United States
facility: PRO Research
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Bensalem
country: United States
facility: Neshaminy Medical, PC
state: Pennsylvania
city: Broomall
country: United States
facility: Medical Group @ Marple Commons
state: Pennsylvania
city: Erie
country: United States
facility: Westminster Family Medicine
state: Pennsylvania
city: Feasterville
country: United States
facility: Feasterville Family Health Care Center
state: Pennsylvania
city: Havertown
country: United States
facility: Southeastern Pennsylvania Medical Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Radiant Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Radiant Research - Reading
state: Pennsylvania
city: Woonsocket
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research - Anderson
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Johnson City
country: United States
facility: Harmony Research, Inc.
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: Walter F. Chase, MD, PA
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center, LLP
state: Texas
city: Salt Lake City
country: United States
facility: Intermoutain Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Radiant Research - Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Lakewood
country: United States
facility: Radiant Research - Tacoma
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare, SC
state: Wisconsin
city: Oregon
country: United States
facility: Dean Medical Center - Oregon Clinic
state: Wisconsin
Study officials:
References:
citation: Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.
citation: Altman RD, Dreiser RL, Fisher CL, Chase WF, Dreher DS, Zacher J. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009 Sep;36(9):1991-9. doi: 10.3899/jrheum.081316. Epub 2009 Jul 31.