drugset / Trial / NCT01125917
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.
Timeline
- Start
- 2004-06
- Primary completion
- 2005-09
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 5 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 10 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 20 ug | Other |
Indications
No indication recorded.