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NCT01148537 · ClinicalTrials.gov registry record · Phase 1
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT01148537: Completed Phase 1 study of Healthy Volunteers, sponsored by Purdue Pharma.
NCT01148537 is a Phase 1 study of Healthy Volunteers that has completed, run by Purdue Pharma. The registered enrollment target is 132 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01148537, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
Primary Outcome
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Conditions Studied
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Matching placebo transdermal patch
- DRUG Avelox (moxifloxacin hydrochloride) tablet
Study Locations (1)
Texas
- PPD Development, LP, Clinics - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2004-07 |
| Est. Completion | 2004-12 |
| Phase | Phase 1 |
What the finished NCT01148537 record still lists
NCT01148537 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT01148537 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01148537 about?
NCT01148537 is a clinical study titled "The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers". The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
What is the current status of trial NCT01148537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2004-07. Estimated completion is 2004-12.
What conditions does trial NCT01148537 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01148537?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Matching placebo transdermal patch (DRUG), Avelox (moxifloxacin hydrochloride) tablet (DRUG).
Who is sponsoring clinical trial NCT01148537?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01148537 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01148537's enrollment target sits among peer trials
132 65th of 283 higher than 217 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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