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

Back Pain Clinical Trial

— BP96-0604  

Official title:

A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315445
• Other study ID #: BP96-0604
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2006
• Last updated: August 27, 2012
• Start date: December 1997
• Est. completion date: May 1998

Study information

• Verified date: August 2012
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 1998
• Est. primary completion date: May 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain

Intervention

Drug:
• Buprenorphine transdermal patch
Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
• Placebo oxycodone/acetaminophen tablets
Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
• OXY/APAP
5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
• Placebo transdermal patch (TDS)
Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Locations

Country	Name	City	State
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Research Across America	Dallas	Texas
United States	Atlanta Research Center	Decatur	Georgia
United States	Gainesville Clinical Research Center	Gainesville	Florida
United States	Rheumatology Associates of North Alabama	Huntsville	Alabama
United States	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri
United States	New Jersey Research Foundation	Linwood	New Jersey
United States	SeaView Research	Miami	Florida
United States	Phoenix Center for Clinical Research	Phoenix	Arizona
United States	Phoenix Orthopedic Center, Ltd.	Phoenix	Arizona
United States	Park Place Therapeutic Center	Plantation	Florida
United States	North Carolina Clinical Research, Inc.	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	"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)	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.	Day 84, or, if applicable, at early termination	No
Secondary	"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)	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.	Day 84	No
Secondary	"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)	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.	Day 84	No
Secondary	"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	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.	Day 84	No
Secondary	"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	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.	Day 84	No
Secondary	"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	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.	Day 84	No
Secondary	"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	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.	Day 84	No
Secondary	"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)	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.	Day 84	No
Secondary	Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)	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."	Day 84	No
Secondary	Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)	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."	Day 84	No
Secondary	Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)	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."	Day 84	No
Secondary	Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)	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."	Day 84	No
Secondary	Time to Stable Pain Management	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).	Start of study to day 21.	No
Secondary	The Time to Discontinuation 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.	Time after dosing to dropout due to lack of efficacy	No

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