NCT01871285

Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film

An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine
DRUG	Placebo film	Matching placebo buccal film
DRUG	Oxycodone	Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets
DRUG	Morphine sulfate	Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets
DRUG	Placebo capsule	Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-06-06
• Last updated: 2017-02-27
• Results posted: 2016-02-03

Locations

3 sites across 1 country: United States