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NCT02307864 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
A Phase 1 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT02307864: Completed Phase 1 study, sponsored by Janssen Scientific Affairs.
NCT02307864 is a Phase 1 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02307864, a Phase 1 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc).
Primary Outcome
The QT interval corrected for heart rate (QTc interval) using Fridericia, Bazett and study-specific power correction methods, will be measured by electrocardiograms (ECG).
Interventions
- DRUG Moxifloxacin Placebo
- DRUG Moxifloxacin 400 mg
- DRUG Tramadol HCl
- DRUG Tramadol HCl Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-12-04 |
| Est. Completion | 2015-08-27 |
| Phase | Phase 1 |
What the finished NCT02307864 record still lists
NCT02307864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin Placebo is the first listed.
NCT02307864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02307864 about?
NCT02307864 is a clinical study titled "Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants". The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc).
What is the current status of trial NCT02307864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2014-12-04. Estimated completion is 2015-08-27.
What interventions are being tested in trial NCT02307864?
The interventions under investigation include: Moxifloxacin Placebo (DRUG), Moxifloxacin 400 mg (DRUG), Tramadol HCl (DRUG), Tramadol HCl Placebo (DRUG).
Who is sponsoring clinical trial NCT02307864?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02307864's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 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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