Trials / Completed
CompletedNCT01148537
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Purdue Pharma LP · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
Detailed description
Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine transdermal patch | Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h. |
| DRUG | Matching placebo transdermal patch | Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20. |
| DRUG | Avelox (moxifloxacin hydrochloride) tablet | Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13 |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2004-12-01
- Completion
- 2004-12-01
- First posted
- 2010-06-22
- Last updated
- 2012-09-03
- Results posted
- 2010-09-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01148537. Inclusion in this directory is not an endorsement.