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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

April 17, 2006
August 27, 2012
December 1997
May 1998   (final data collection date for primary outcome measure)
  • 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).
Pain on the average and pain right now scores on days 1, 7, 21, 30, 45, 60, 75, 84, and, if applicable, at early termination.
Complete list of historical versions of study NCT00315445 on ClinicalTrials.gov Archive Site
  • "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.
  • Discontinuation due to lack of efficacy
  • Medical Outcomes Study health survey
  • therapeutic response
  • patient preference
  • daily patient diary for average pain
  • time to stable pain management
  • number of post-titration dose adjustments
  • patient satisfaction.
Not Provided
Not Provided
 
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Back Pain
  • Drug: Buprenorphine transdermal patch
    Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
    Other Name: Butrans™
  • Drug: Placebo oxycodone/acetaminophen tablets
    Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
  • Drug: OXY/APAP
    5 mg oxycodone / 325 mg 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
  • Placebo Comparator: Placebo
    Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20
    Interventions:
    • Drug: Placebo oxycodone/acetaminophen tablets
    • Drug: Placebo transdermal patch (TDS)
  • Active Comparator: OXY/APAP
    5 mg oxycodone/325 mg acetaminophen tablets
    Intervention: Drug: OXY/APAP
  • Experimental: BTDS
    Buprenorphine transdermal patch 5, 10, or 20 mcg/hour
    Intervention: Drug: Buprenorphine transdermal patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
May 1998
May 1998   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315445
BP96-0604
Not Provided
Medical Director, Medical Research, Purdue Pharma L.P.
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP