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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 is a Phase 1 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 68 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02307864
The ClinicalTrials.gov registry entry for NCT02307864 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin Placebo is the first listed.
NCT02307864 reports 0 study locations.
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.
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