The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

NCT00315445 | Completed Phase 3 Results

• 1 other identifier: BP96-0604
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 12

Brief Summary

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Conditions

Back Pain

Keywords

chronic back pain; opioid; transdermal

Outcome Measures

Primary Outcomes (2)

• Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])

  Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.

  On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

• Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)

  Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Pain right now is presented as the LSmean \[change from baseline\] (SE).

  Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

Secondary Outcomes (14)

• "Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)

  Day 84, or, if applicable, at early termination

• "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)

  Day 84

• "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)

  Day 84

• "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)

  Day 84

• "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)

  Day 84

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20

Drug: Placebo oxycodone/acetaminophen tablets; Drug: Placebo transdermal patch (TDS)

OXY/APAP

ACTIVE COMPARATOR

5 mg oxycodone/325 mg acetaminophen tablets

Drug: OXY/APAP

BTDS

EXPERIMENTAL

Buprenorphine transdermal patch 5, 10, or 20 mcg/hour

Drug: Buprenorphine transdermal patch

Interventions

Buprenorphine transdermal patch DRUG

Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.

Also known as: Butrans™

BTDS

Placebo oxycodone/acetaminophen tablets DRUG

Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

Placebo

OXY/APAP DRUG

5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

OXY/APAP

Placebo transdermal patch (TDS) DRUG

Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Placebo

Eligibility Criteria

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

You may qualify if:

• clinical evidence of stable, chronic (\>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
• unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking \</=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

You may not qualify if:

• receiving opioids at an average daily dose of \>90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
• scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (12)

Rheumatology Associates of North Alabama

Huntsville, Alabama, 35801, United States

Location

Phoenix Center for Clinical Research

Phoenix, Arizona, 85015, United States

Location

Phoenix Orthopedic Center, Ltd.

Phoenix, Arizona, 85023, United States

Location

Gainesville Clinical Research Center

Gainesville, Florida, 32605, United States

Location

SeaView Research

Miami, Florida, 33134, United States

Location

Park Place Therapeutic Center

Plantation, Florida, 33324, United States

Location

Atlanta Research Center

Decatur, Georgia, 30033, United States

Location

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, 64114, United States

Location

New Jersey Research Foundation

Linwood, New Jersey, 08221, United States

Location

North Carolina Clinical Research, Inc.

Raleigh, North Carolina, 27607, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Buprenorphine; Acetaminophen; tyramine-deoxysorbitol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, 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; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

There was a large percentage of discontinuations across treatment groups.

Results Point of Contact

• Title: Medical Director
• 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2006
• First Posted: April 18, 2006
• Study Start: December 1, 1997
• Primary Completion: May 1, 1998
• Study Completion: May 1, 1998
• Last Updated: September 3, 2012
• Results First Posted: August 10, 2011

Record last verified: 2012-08

Locations

US (12)