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

• Status: Completed
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

Criteria

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.