Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

Chronic Pain Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531427
• Other study ID #: BUP3025
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2007
• Last updated: September 5, 2012
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: September 2012
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Description:

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: November 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,

• clinical diagnosis of OA of the knee 1 year or longer,

• subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,

• subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Exclusion Criteria:

• subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,

• subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,

• subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Buprenorphine
transdermal system 10 and 20 applied for 7-day wear
• Placebo
transdermal system (placebo) applied for 7-day wear

Locations

Country	Name	City	State
United States	Research Facility	Anaheim	California
United States	Research Facility	Atlanta	Georgia
United States	Research Facility	Augusta	Georgia
United States	Research Facility	Austin	Texas
United States	Stat-Lab I, Inc.	Baton Rouge	Louisiana
United States	Research Facility	Bay City	Michigan
United States	Lovelace Scientific Resources, Inc.	Beverly Hills	California
United States	Premier Internal Medicine	Biloxi	Mississippi
United States	AMR Research Associates	Bogart	Georgia
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Coastal Pain Management	Bradenton	Florida
United States	Paramount Clinical Research	Bridgeville	Pennsylvania
United States	Research Facility	Brockton	Massachusetts
United States	Research Facility	Canton	Ohio
United States	Radiant Research, Phoenix Southeast	Chandler	Arizona
United States	Catalina Research Institute	Chino	California
United States	Research Facility	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Research Facility	Clearwater	Florida
United States	Research Facility	Colleyville	Texas
United States	Research Facility	Columbus	Ohio
United States	Research Facility	Columbus	Ohio
United States	New England Center for Clinical Research	Cranston	Rhode Island
United States	Research Facility	Cranston	Rhode Island
United States	Research Facility	Dallas	Texas
United States	Research Facility	Dawsonville	Georgia
United States	Digestive Endoscopy Center	Dayton	Ohio
United States	Research Facility	Dayton	Ohio
United States	Research Facility	Decatur	Georgia
United States	Research Facility	Downey	California
United States	Research Facility	Duncansville	Pennsylvania
United States	Research Facility	Eugene	Oregon
United States	Research Facility	Florissant	Missouri
United States	Research Facility	Foothill Ranch	California
United States	Research Facility	Frederick	Maryland
United States	Greenville Pharmaceutical Research	Greenville	South Carolina
United States	East Coast Clinical Research	Haverhill	Massachusetts
United States	Research Facility	Henderson	Nevada
United States	Research Facility	Honolulu	Hawaii
United States	Rehabilitation Association of IN	Indianapolis	Indiana
United States	Arthritis Clinic, PLLC	Jackson	Tennessee
United States	Research Facility	Jupiter	Florida
United States	Research Facility	Laguna Hills	California
United States	Oyster Point Family Health Ctr	Lancaster	Pennsylvania
United States	Research Facility	Largo	Florida
United States	Research Facility	Littleton	Colorado
United States	Research Facility	Marietta	Georgia
United States	Research Facility	Mechanicsburg	Pennsylvania
United States	Research Facility	Medford	Oregon
United States	Pharmax Research Clinic	Miami	Florida
United States	Research Facility	Miami	Florida
United States	Research Facility	Middleburg Heights	Ohio
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Research Facility	Morgantown	North Carolina
United States	Research Facility	Mt. Gilead	Ohio
United States	Research Facility	Nederland	Texas
United States	Research Facility	New Iberia	Louisiana
United States	Research Facility	New Orleans	Louisiana
United States	Research Facility	New York	New York
United States	Research Facility	New York	New York
United States	NDC Medical Center	Norfolk	Virginia
United States	Research Facility	Oklahoma City	Oklahoma
United States	Research Facility	Orlando	Florida
United States	Research Facility	Overland Park	Kansas
United States	Arizona Research Center, Inc.	Phoenix	Arizona
United States	Research Facility	Phoenix	Arizona
United States	Research Facility	Phoenix	Arizona
United States	Research Facility	Plantation	Florida
United States	Research Facility	Royal Palm	Florida
United States	Research Facility	Sacramento	California
United States	Research Facility	Salt Lake City	Utah
United States	Research Facility	San Antonio	Texas
United States	Research Facility	San Antonio	Texas
United States	Research Facility	Springfield	Massachusetts
United States	Research Facility	St. Louis	Missouri
United States	Sports Med Consultants PC	St. Louis	Missouri
United States	Research Facility	Stamford	Connecticut
United States	Research Facility	Sugarland	Texas
United States	Pacific Northwest Primary Care	Tacoma	Washington
United States	Clinical Research of West Flor	Tampa	Florida
United States	Research Facility	Tampa	Florida
United States	Research Facility	Toledo	Ohio
United States	Research Facility	Venice	Florida
United States	Independence Family Medicine	Virginia Beach	Virginia
United States	Research Facility	West Palm Beach	Florida
United States	Research Facility	West Reading	Pennsylvania
United States	Research Facility	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.	"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.	24 hours (week 12)	No
Secondary	Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.	Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).	10 weeks	No
Secondary	Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.	The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.	Weeks 4, 8, and 12 of the double-bind phase	No

External Links

•   Product Information