Buprenorphine Transdermal System (BTDS) in Subjects w/Moderate-Severe Chronic Pain Due to Osteoarthritis (OA) of Knee - Full Text View

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00531427

Purpose

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 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 post randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Condition	Intervention	Phase
Chronic Pain Osteoarthritis of the Knee	Drug: Buprenorphine Drug: Placebo	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

The 'average pain over the last 24 hours' score of the study knee at week 12 of the double blind phase. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The daily number of tablets of non opioid supplemental analgesic medications taken during weeks 2 through 12 of the double-blind phase and the Sleep Disturbance Subscale of the Medical Outcome Study (MOS) Sleep Scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	520
Study Start Date:	September 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Buprenorphine transdermal delivery system 10 and 20 worn for 7 days	Drug: Buprenorphine transdermal delivery system 10 and 20 worn for 7 days
2: Placebo Comparator	Drug: Placebo transdermal delivery system (placebo) worn for 7 days

Detailed 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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

subjects with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition,
clinical diagnosis of OA of the knee one year or longer,
subjects treated within the 14 days prior to screening with non opioid 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 non opioid 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531427

Contacts

Contact: Karen Ventrella

1-800-745-7445 ext 7387

karen.ventrella@pharma.com

Show 88 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

Responsible Party:	Purdue Pharma L.P. ( Medical Monitor )
Study ID Numbers:	BUP3025
Study First Received:	September 17, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00531427
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Chronic pain,
OA of the knee,
opioid,
transdermal

Study placed in the following topic categories:

Signs and Symptoms
Osteoarthritis, Knee
Buprenorphine
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Neurologic Manifestations
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009