Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study

Purdue Pharma LP189 enrolled

Overview

The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

189

Conditions

Chronic Nonmalignant Pain

Interventions

Buprenorphine transdermal patchDRUG

Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Include: * Subjects of either sex aged 18 years or older. * Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension. Exclusion Criteria: Include: * Subjects currently receiving daily morphine or oxycodone (mono-therapy). * Subjects who are discontinued from BUP3201 due to adverse events. * Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period. Refer to core study for additional inclusion/exclusion information.

Locations (19)

Arizona Research Center Inc.

Phoenix, Arizona, United States

Clinical Research Consultants Inc

Trumbull, Connecticut, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) as a Measure of Safety.

Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.

Time frame: 28 weeks

Data from ClinicalTrials.gov

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