Clinical trial NCT00108771: Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain
Official title: Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Pain
Chronic Pain
Osteoarthritis Pain
Osteoarthritis
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-19
Enrollment: 202
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.

Detailed description: This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.

Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.

Exclusion Criteria:

* Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.

Primary outcomes:
measure: WOMAC Knee and Hip Osteoarthritis Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 weeks
measure: TOPS survey
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Reserach Center
state: Arizona
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Daytona Beach
country: United States
facility: Radiant Research
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group
state: Florida
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Pain Trials Center - Brigham & Women's Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Phase III Clinical Trials
state: Massachusetts
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Analgesic Development Ltd.
state: New York
Study officials:
affiliation: Radiant Research
name: Frank Farmer, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: