drugset / Trial / NCT01871285
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
RandomizedCrossoverQuadruple-blindSupportive care
Summary
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or reversing analgesic effects.
Timeline
- Start
- 2013-06
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 300 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 450 ug | Other |
| Subject | Morphine | Other / unclassified | 15 mg | Oral |
| Subject | Morphine | Other / unclassified | 30 mg | Oral |
| Subject | Morphine | Other / unclassified | 60 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 5 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 10 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 15 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 20 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 30 mg | Oral |
Indications
No indication recorded.