About Pricing FAQs Blog

Loading clinical trials...

Your health journey, clearly organized.

Find Clinical Trials →

Legal

Privacy Policy
Terms of Service

© 2026 Clareo Health. All rights reserved.

Back to clinical trial search

COMPLETEDPhase 3NCT00315887

The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in...

Lead sponsor: Purdue Pharma LP•22 U.S. locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Clareo turns complex medical information into clear understanding you can use.

Bring this clarity to your next appointment.

Keep all your medical notes and next steps in one place.

Sponsors

Lead Sponsor

Purdue Pharma LP

Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
•back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

Exclusion Criteria

•receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
•scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Related studies

Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

NCT06821607 · Chronic Low Back Pain

Comparative Effects of Cognitive Functional Therapy With Kinetic Control Training on Non-specific Low Back Pain

NCT07282925 · Low Back Pain, Non Specific Chronic Low Back Pain

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

NCT03836248 · Chronic Low Back Pain

Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial

NCT07304076 · Chronic Low Back Pain (CLBP)

The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain

NCT07132762 · Chronic Low Back Pain

View all related studies →

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 3, 2006Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment250

Start dateApr 1999

Last updatedMay 3, 2006

Condition

Chronic Low Back Pain

Locations shown

Rheumatology Associates of North Alabama

Huntsville, Alabama

Arizona Research Center

Phoenix, Arizona

Arthritis Center of Connecticut

Waterbury, Connecticut

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2006Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions