# The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

> **NCT00315445** · PHASE3 · COMPLETED · sponsor: **Purdue Pharma LP** · enrollment: 134 (actual)

## Conditions studied

- Back Pain

## Interventions

- **DRUG:** Buprenorphine transdermal patch
- **DRUG:** Placebo oxycodone/acetaminophen tablets
- **DRUG:** OXY/APAP
- **DRUG:** Placebo transdermal patch (TDS)

## Key facts

- **NCT ID:** NCT00315445
- **Lead sponsor:** Purdue Pharma LP
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 1997-12
- **Primary completion:** 1998-05
- **Final completion:** 1998-05
- **Target enrollment:** 134 (ACTUAL)
- **Last updated:** 2012-09-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00315445

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00315445, "The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT00315445. Licensed CC0.

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