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NCT01363323 · ClinicalTrials.gov registry record · Phase 1
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 546
- Enrollment target
NCT01363323 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 546 participants.
The verdict
NCT01363323, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 546 participants
- Enrollment target
Study Summary
This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Methylnaltrexone (MNTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2004-11 |
| Est. Completion | 2005-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363323
The ClinicalTrials.gov registry entry for NCT01363323 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01363323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01363323 about?
NCT01363323 is a clinical study titled "Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization". This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and suprat...
What is the current status of trial NCT01363323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 546 participants. The study started on 2004-11. Estimated completion is 2005-02.
What interventions are being tested in trial NCT01363323?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01363323?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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