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NCT02243241 · ClinicalTrials.gov registry record · Phase 1

The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects

A Phase 1 study, sponsored by Purdue Pharma.

Completed
Registry status
Phase 1
Development phase
208
Enrollment target

NCT02243241 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 208 participants.

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The verdict

NCT02243241, a Phase 1 study, has completed, sponsored by Purdue Pharma.

COMPLETED
Registry status
Phase 1
Development phase
208 participants
Enrollment target

Study Summary

Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg tablets) on the QT/QTc interval.

Interventions

  • DRUG Moxifloxacin
  • DRUG Placebo for moxifloxacin
  • DRUG HYD
  • DRUG Placebo for HYD

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2012-11
Est. Completion 2013-05
Phase Phase 1

Sponsor

Purdue Pharma

54 total trials

What the Registry Record Tells You About NCT02243241

The ClinicalTrials.gov registry entry for NCT02243241 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 208 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 0 conditions, and to 4 interventions - of which Moxifloxacin is the first listed.

NCT02243241 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02243241 about?

NCT02243241 is a clinical study titled "The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects". Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg tablets) on the QT/QTc interval.

What is the current status of trial NCT02243241?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2012-11. Estimated completion is 2013-05.

What interventions are being tested in trial NCT02243241?

The interventions under investigation include: Moxifloxacin (DRUG), Placebo for moxifloxacin (DRUG), HYD (DRUG), Placebo for HYD (DRUG).

Who is sponsoring clinical trial NCT02243241?

This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.

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.