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NCT01999114 · ClinicalTrials.gov registry record · Phase 1
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
A Phase 1 study of ECG Effects, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 328
- Enrollment target
- 1
- Study location
NCT01999114: Completed Phase 1 study of ECG Effects, sponsored by Purdue Pharma.
NCT01999114 is a Phase 1 study of ECG Effects that has completed, run by Purdue Pharma. The registered enrollment target is 328 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (447% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999114, a Phase 1 study of ECG Effects, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 328 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
Primary Outcome
The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS
Conditions Studied
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Naltrexone tablet
- DRUG Placebos (for TDS and for naltrexone and for moxifloxacin)
- DRUG Moxifloxacin tablet
Study Locations (1)
Texas
- PPD Phase I Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT01999114 record still lists
NCT01999114 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (447% higher).
The record links to 1 condition, with ECG Effects appearing as the primary indexed condition, and to 4 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT01999114 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01999114 about?
NCT01999114 is a clinical study titled "The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers". The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
What is the current status of trial NCT01999114?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 328 participants. The study started on 2012-03. Estimated completion is 2012-10.
What conditions does trial NCT01999114 study?
This clinical trial studies the following conditions: ECG Effects.
What interventions are being tested in trial NCT01999114?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Naltrexone tablet (DRUG), Placebos (for TDS and for naltrexone and for moxifloxacin) (DRUG), Moxifloxacin tablet (DRUG).
Who is sponsoring clinical trial NCT01999114?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01999114 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
How this trial's enrollment target compares
Where NCT01999114's enrollment target sits among peer trials
328 111th of 2000 higher than 1,890 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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