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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 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.

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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.

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

FieldValue
Enrollment Target 132 participants
Start Date 2004-07
Est. Completion 2004-12
Phase Phase 1

Sponsor

Purdue Pharma

54 total trials

What the Registry Record Tells You About NCT01148537

The ClinicalTrials.gov registry entry for NCT01148537 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower). The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.