Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
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ClinicalTrials.gov Identifier: NCT00312221 |
Recruitment Status :
Terminated
(terminated early for administrative reasons unrelated to safety or efficacy)
First Posted : April 7, 2006
Results First Posted : September 15, 2010
Last Update Posted : September 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Drug: Buprenorphine Drug: oxycodone immediate-release | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 418 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | July 2005 |
Actual Study Completion Date : | August 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
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Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Name: Butrans™ |
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
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Drug: Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Name: Butrans™ |
Experimental: Oxycodone Immediate-Release (Oxy IR) 40 mg
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
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Drug: oxycodone immediate-release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). |
- "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase. [ Time Frame: Weeks 4, 8, and 12 of the double-blind phase ]The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
- The Mean Daily Number of Supplemental Analgesic Medication Tablets [ Time Frame: Double-blind phase (84 days) ]The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.
- The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase [ Time Frame: Weeks 4, 8 and 12 of the double-blind phase ]
The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.
The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst).
- The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: 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 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 and Questions 2 to 12 are scored on a scale of 1 to 6. 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.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
Exclusion Criteria:
- Not currently taking and tolerating opioids.
- Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.
Other protocol-specific exclusion/inclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312221

Responsible Party: | Purdue Pharma LP |
ClinicalTrials.gov Identifier: | NCT00312221 |
Other Study ID Numbers: |
BUP3019 |
First Posted: | April 7, 2006 Key Record Dates |
Results First Posted: | September 15, 2010 |
Last Update Posted: | September 10, 2012 |
Last Verified: | September 2012 |
Osteoarthritis, opioid, transdermal |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Oxycodone Buprenorphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |