Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement

NCT00403234 | Terminated Phase 2 Results

• 1 other identifier: BUP2003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug. Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.

Conditions

Postoperative Pain

Keywords

Postoperative pain; opioid; transdermal; TKA (total knee arthroplasty)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) as a Measure of Safety

  Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.

  From signed informed consent to 7 days after end of study (approx. 35 days)

Study Arms (4)

BTDS 10

EXPERIMENTAL

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

Drug: Buprenorphine transdermal patch

BTDS 20

EXPERIMENTAL

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Drug: Buprenorphine transdermal patch

BTDS 30

EXPERIMENTAL

Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear

Drug: Buprenorphine transdermal patch

Placebo TDS

PLACEBO COMPARATOR

Placebo patches were similar to BTDS 10 and 20.

Drug: Placebo BTDS

Interventions

Buprenorphine transdermal patch DRUG

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.

Also known as: Butrans™

BTDS 10

Placebo BTDS DRUG

Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.

Placebo TDS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
• Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.

You may not qualify if:

• Subjects who have pain or disability in a site other than the operative joint.
• Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
• Subjects whose body mass index (BMI) is 40 or more.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (5)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Accurate Clinical Trials, Inc

San Clemente, California, 92672, United States

Location

Southeastern Clinical Research Consultants

Orlando, Florida, 32804, United States

Location

Greater Chesapeake Orthopaedic Associates

Baltimore, Maryland, 21218, United States

Location

Sewickley Valley Hospital

Sewickley, Pennsylvania, 15143, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

This trial was terminated early due to administrative reasons not related to efficacy or safety. The efficacy data are not presented since the objective of this study was changed prior to study unblinding, identifying it as a safety study.

Results Point of Contact

• Title: Clinical Leader, Director of Clinical Research
• Organization: Purdue Pharma L.P.

800-733-1333

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 3, 2012
• Results First Posted: September 21, 2010

Record last verified: 2012-08

Locations

US (5)