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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: Completed Phase 1 study, sponsored by Purdue Pharma.

NCT02243241 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 208 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The electrocardiogram (ECG) effects of HYD 80 mg (day 9) 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
Purdue Pharma

54 total trials

What the finished NCT02243241 record still lists

NCT02243241 is an interventional study that assigns participants to a tested intervention. The registered 208 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 (247% higher).

The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin is the first listed.

NCT02243241 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02243241's enrollment target sits among peer trials

208 250th of 2000 higher than 1,749 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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Source: ClinicalTrials.gov NCT02243241, the US trial registry maintained by the National Library of Medicine. NCT02243241 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.