Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00312221
• Other study ID #: BUP3019
• Status: Terminated
• Phase: Phase 3
• First received: April 6, 2006
• Last updated: September 5, 2012
• Start date: April 2004
• Est. completion date: August 2005

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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Description:

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 418
• Est. completion date: August 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
• Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
• oxycodone immediate-release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Locations

Country	Name	City	State
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Professional Clinical Research Crystal Lake Health Center	Benzonia	Michigan
United States	Parkway Medical Center	Birmingham	Alabama
United States	Miray Medical Center	Brockton	Massachusetts
United States	International Clinical Research Network	Chula Vista	California
United States	Pharm Quest	Greensboro	North Carolina
United States	Med Search Professional Group/Pharmaceutical C-Trials Inc.	Hurst	Texas
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Drug Study Institute	Jupiter	Florida
United States	Rheumatology PC	Kalamazoo	Michigan
United States	Innovative Research of West Florida, Inc.	Largo	Florida
United States	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky
United States	Georgia Medical Research Institute	Marietta	Georgia
United States	Non- Surgical Orthopedic & Spine Center, P.C.	Marietta	Georgia
United States	International Medical Research	Ormond Beach	Florida
United States	Peninsula Research, Inc.	Ormond Beach	Florida
United States	Southern Colorado Clinic	Pueblo	Colorado
United States	Clinical Trials Research	Roseville	California
United States	Texas Medical Research Associates	San Antonio	Texas
United States	Accelovance	San Diego	California
United States	The Arthritis Center	Springfield	Illinois
United States	Torrance Clinical Research	Torrance	California
United States	Palm Beach Research Center	West Palm Beach	Florida

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" Scores at 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).	Weeks 4, 8, and 12 of the double-blind phase	No
Secondary	The Mean Daily Number of Supplemental Analgesic Medication Tablets	The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.	Double-blind phase (84 days)	No
Secondary	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	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).	Weeks 4, 8 and 12 of the double-blind phase	No
Secondary	The Sleep Disturbance Subscale in The Medical Outcomes (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 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.	Weeks 4, 8, and 12 of the Double-blind Phase	No

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