The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (BP96-0604)

• ClinicalTrials.gov Identifier: NCT00315445
• Recruitment Status: Completed
• First Posted: April 18, 2006
• Results First Posted: August 10, 2011
• Last Update Posted: September 3, 2012
• Sponsor: Purdue Pharma LP
• Information provided by: Purdue Pharma LP

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Back Pain	Drug: Buprenorphine transdermal patch; Drug: Placebo oxycodone/acetaminophen tablets; Drug: OXY/APAP; Drug: Placebo transdermal patch (TDS)	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
• Study Start Date: December 1997
• Actual Primary Completion Date: May 1998
• Actual Study Completion Date: May 1998

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20	Drug: Placebo oxycodone/acetaminophen tablets; Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.; Drug: Placebo transdermal patch (TDS); Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
Active Comparator: OXY/APAP; 5 mg oxycodone/325 mg acetaminophen tablets	Drug: OXY/APAP; 5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Experimental: BTDS; Buprenorphine transdermal patch 5, 10, or 20 mcg/hour	Drug: Buprenorphine transdermal patch; Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.; Other Name: Butrans™

Outcome Measures

Primary Outcome Measures :

1. Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) [ Time Frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. ]
   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.
2. Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) [ Time Frame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. ]
   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).

Secondary Outcome Measures :

1. "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) [ Time Frame: Day 84, or, if applicable, at early termination ]
   The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. "Physical Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
2. "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) [ Time Frame: Day 84 ]
   The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. "Physical Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
3. "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF) [ Time Frame: Day 84 ]
   The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Bodily Pain" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
4. "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]
   The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "General Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed.
5. "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]
   The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Vitality" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
6. "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]
   The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Social Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
7. "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]
   The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Emotional Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
8. "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]
   The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Mental Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
9. Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ]
   The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
10. Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) [ Time Frame: Day 84 ]
    The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
11. Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ]
    The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = "Worse than prestudy medicine" to 2 = "Better than prestudy medicine."
12. Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ]
    The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
13. Time to Stable Pain Management [ Time Frame: Start of study to day 21. ]
    For each subject, "time to stable pain management" is defined as the first (post-baseline) time during the titration period when his/her "diary pain" was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the "pain on the average" (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline).
14. The Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Time after dosing to dropout due to lack of efficacy ]
    Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Locations

United States, Alabama

Rheumatology Associates of North Alabama

Huntsville, Alabama, United States, 35801

United States, Arizona

Phoenix Center for Clinical Research

Phoenix, Arizona, United States, 85015

Phoenix Orthopedic Center, Ltd.

Phoenix, Arizona, United States, 85023

United States, Florida

Gainesville Clinical Research Center

Gainesville, Florida, United States, 32605

SeaView Research

Miami, Florida, United States, 33134

Park Place Therapeutic Center

Plantation, Florida, United States, 33324

United States, Georgia

Atlanta Research Center

Decatur, Georgia, United States, 30033

United States, Missouri

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, United States, 64114

United States, New Jersey

New Jersey Research Foundation

Linwood, New Jersey, United States, 08221

United States, North Carolina

North Carolina Clinical Research, Inc.

Raleigh, North Carolina, United States, 27607

United States, Texas

Research Across America

Dallas, Texas, United States, 75234

Metroplex Clinical Research Center

Dallas, Texas, United States, 75235

Sponsors and Collaborators

Purdue Pharma LP

More Information

Additional Information:

Product Information 

• Responsible Party: Medical Director, Medical Research, Purdue Pharma L.P.
• ClinicalTrials.gov Identifier: NCT00315445
• Other Study ID Numbers: BP96-0604
• First Posted: April 18, 2006
• Results First Posted: August 10, 2011
• Last Update Posted: September 3, 2012
• Last Verified: August 2012

Keywords provided by Purdue Pharma LP:

chronic back pain; opioid; transdermal

Additional relevant MeSH terms:

Back Pain; Pain; Neurologic Manifestations; Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Buprenorphine; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Narcotic Antagonists; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents