Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Stopped early · Phase 3

Conditions studied: Back Pain Lower Back Chronic

In brief

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00313014

Run by

Purdue Pharma LP

People needed

660

Starts

2004-02-01

Expected to finish

2005-09-01

Last updated by the study team

2012-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• low back pain for 3 months or longer, confirmed by radiographic evidence.
• receiving a stable dose of an opioid analgesic for low back pain.

You may not qualify if…

• taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
• requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Arthritis Clinical Intervention Program — Birmingham, Alabama, United States
• Winston Physician Services, LLC — Haleyville, Alabama, United States
• Arizona Research Center, Inc. — Phoenix, Arizona, United States
• Radiant Research — Phoenix, Arizona, United States
• Advanced Clinical Therapeutics — Tuscon, Arizona, United States
• Hot Springs Pain Clinic — Hot Springs, Arkansas, United States
• NuLife Clinical Research, Inc. — Anaheim, California, United States
• Lovelace Scientific Resources, Inc. — Beverly Hills, California, United States
• Northern California Research Corp — Carmichael, California, United States
• International Clinical Research Network — Chula Vista, California, United States
• Shreenath Clinical Service — Fountain Valley, California, United States
• U of Calif at Davis, Med Ctr, Pain Management Center — Sacramento, California, United States
• Accelovance — San Diego, California, United States
• Southern Colorado Clinic — Pueblo, Colorado, United States
• Chiefland Medical Center — Chiefland, Florida, United States
• University Clinical Research, Inc. — DeLand, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Innovative Research of West Florida, Inc. — Largo, Florida, United States
• Renstar Medical — Ocala, Florida, United States
• Peninsula Research Inc. — Ormond Beach, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Gold Coast Research, LLC — Plantation, Florida, United States
• Coastal Medical Research — Port Orange, Florida, United States
• Birmingham Pain Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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