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

This study has been completed.
Sponsor:
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00315445
First received: April 17, 2006
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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:
  • "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 ] [ Designated as safety issue: No ]
    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.

  • "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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."

  • Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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."

  • Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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."

  • Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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."

  • Time to Stable Pain Management [ Time Frame: Start of study to day 21. ] [ Designated as safety issue: No ]
    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).

  • The Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Time after dosing to dropout due to lack of efficacy ] [ Designated as safety issue: No ]
    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.


Enrollment: 134
Study Start Date: December 1997
Study Completion Date: May 1998
Primary Completion Date: May 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315445

Locations
United States, Alabama
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Phoenix Orthopedic Center, Ltd.
Phoenix, Arizona, United States, 85023
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
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
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235
Research Across America
Dallas, Texas, United States, 75234
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Medical Research, Purdue Pharma L.P.
ClinicalTrials.gov Identifier: NCT00315445     History of Changes
Other Study ID Numbers: BP96-0604
Study First Received: April 17, 2006
Results First Received: May 17, 2011
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
chronic back pain
opioid
transdermal

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Buprenorphine
Oxycodone
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014