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

History of Changes

Results First Received: May 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Back Pain
Interventions:	Drug: Buprenorphine transdermal patch Drug: Placebo oxycodone/acetaminophen tablets Drug: OXY/APAP Drug: Placebo transdermal patch (TDS)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10-Dec-1997 (first subject, first visit) to 08-May-1998 (last subject last visit) in 13 centers in the United States

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was designed to evaluate the efficacy and safety of BTDS in comparison with current pharmacotherapeutic pain management practice and placebo in opioid-naïve or opioid-experienced adult subjects with chronic back pain not manageable with nonopioid analgesics alone (range, 19–85 years).

Reporting Groups

	Description
Placebo	Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
OXY/APAP	5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
BTDS	Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.

Participant Flow: Overall Study

	Placebo	OXY/APAP	BTDS
STARTED	45	43	46
COMPLETED	18	27	22
NOT COMPLETED	27	16	24
Adverse Event	7	12	15
Lack of Efficacy	16	1	7
Lost to Follow-up	1	0	1
Protocol Violation	2	0	1
unknown	1	3	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
OXY/APAP	5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
BTDS	Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Total	Total of all reporting groups

Baseline Measures

	Placebo	OXY/APAP	BTDS	Total
Number of Participants [units: participants]	45	43	46	134
Age [units: years] Mean ± Standard Deviation	52 ± 2.2	49 ± 2.5	54 ± 2.2	52 ± 1.31
Gender [units: participants]
Female	25	27	28	80
Male	20	16	18	54
Opioid Experience ^[1] [units: participants]
Opioid naive	39	34	34	107
Opioid experienced	6	9	12	27

[1]	Subjects were either classified as "opioid naive" (those not currently receiving an opioid-containing analgesic or those receiving 2 or fewer short-acting opioid tablets or capsules per day) or "opioid experienced" (those receiving a controlled-release opioid analgesic at a dose of ≤ 90 mg of morphine equivalents per day or those receiving 3 to 12 capsules or tablets of short-acting opioid analgesics per day)

[1]

Subjects were either classified as "opioid naive" (those not currently receiving an opioid-containing analgesic or those receiving 2 or fewer short-acting opioid tablets or capsules per day) or "opioid experienced" (those receiving a controlled-release opioid analgesic at a dose of ≤ 90 mg of morphine equivalents per day or those receiving 3 to 12 capsules or tablets of short-acting opioid analgesics per day)

Outcome Measures

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1. Primary:

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. ]

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2. Primary:

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. ]

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3. 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) [ Time Frame: Day 84, or, if applicable, at early termination ]

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Measure Type	Secondary
Measure Title	"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)
Measure Description	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.
Time Frame	Day 84, or, if applicable, at early termination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.

Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Reporting Groups

	Description
Placebo	Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
OXY/APAP	5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
BTDS	Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.

Measured Values

	Placebo	OXY/APAP	BTDS
Number of Participants Analyzed [units: participants]	45	42	46
"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) [units: Units on a scale] Mean ± Standard Error	46.4 ± 4.0	44.5 ± 3.9	46.5 ± 3.6

Statistical Analysis 1 for "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)

Groups ^[1]	Placebo
Day 84 Mean ^[2]	46.4
90% Confidence Interval	( 40.2 to 48.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
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Statistical Analysis 2 for "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)

Groups ^[1]	OXY/APAP
Day 84 Mean ^[2]	44.5
90% Confidence Interval	( 43.3 to 52.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for "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)

Groups ^[1]	BTDS
Day 84 Mean ^[2]	46.5
90% Confidence Interval	( 41.7 to 50.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	No text entered.

4. Secondary:

"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) [ Time Frame: Day 84 ]

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5. Secondary:

"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF) [ Time Frame: Day 84 ]

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6. Secondary:

"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]

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7. Secondary:

"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]

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8. Secondary:

"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]

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9. Secondary:

"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]

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10. Secondary:

"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ]

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11. Secondary:

Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ]

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12. Secondary:

Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) [ Time Frame: Day 84 ]

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13. Secondary:

Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ]

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14. Secondary:

Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ]

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15. Secondary:

Time to Stable Pain Management [ Time Frame: Start of study to day 21. ]

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16. Secondary:

The Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Time after dosing to dropout due to lack of efficacy ]

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17. Post-Hoc:

Sensitivity Analysis: “Pain on the Average” Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF) [ Time Frame: Baseline to days 21 - 84 ]

Show Outcome Measure 17

18. Post-Hoc:

Sensitivity Analysis: “Pain Right Now” Change From Baseline in the Maintenance Period (Days 21–84), BOCF [ Time Frame: Baseline to days 21-84 ]

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19. Post-Hoc:

Sensitivity Analysis "Pain on the Average" Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF) [ Time Frame: Baseline to days 21-84 ]

Show Outcome Measure 19

20. Post-Hoc:

Sensitivity Analysis: "Pain Right Now" Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF) [ Time Frame: Baseline to days 21-84 ]

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21. Post-Hoc:

Sensitivity Analysis: "Pain on the Average" Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF) [ Time Frame: Baseline to day 84 ]

Show Outcome Measure 21

22. Post-Hoc:

Sensitivity Analysis: "Pain Right Now" Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF) [ Time Frame: Baseline to day 84 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There was a large percentage of discontinuations across treatment groups.

Results Point of Contact:

Name/Title: Medical Director
Organization: Purdue Pharma L.P.
phone: 800-733-1333

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

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