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OpenTrials
Completed

NCT Number: NCT01151098

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

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.

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Key information

Conditions

Chronic Nonmalignant Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arizona Research Center Inc., Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buprenorphine transdermal patch

Drug

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

Other names: Butrans™

Primary outcomes

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

    Time frame: 28 weeks

    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.

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Registry information

Official study title

An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jun 25, 2010
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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