Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Non-malignant Pain

Treatments: Drug: Placebo to match BTDS; Drug: Buprenorphine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312195

BUP3201

Details and patient eligibility

About

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Full description

Buprenorphine is a synthetic opioid analgesic with over 25 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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
• Good, very good or excellent pain control on current opioid therapy.
• Willing and able to use a telephone interactive voice response service.

Exclusion criteria

• Currently receiving daily morphine or oxycodone monotherapy.
• Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 2 patient groups, including a placebo group

BTDS (5, 10 or 20)

Experimental group

Description:

Buprenorphine transdermal patch

Treatment:

Drug: Buprenorphine transdermal patch

Placebo to match BTDS

Placebo Comparator group

Description:

Placebo to match buprenorphine transdermal patch

Treatment:

Drug: Placebo to match BTDS