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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 is a Phase 1 study of ECG Effects that has completed, run by Purdue Pharma. The registered enrollment target is 328 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01999114
The ClinicalTrials.gov registry entry for NCT01999114 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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