CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Silenor 6 mg +3 moredrug
Likely dose
Silenor 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02353299
NCT02353299Phase 4Completed
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Phase IV 4 Way Crossover Study to Assess and Compare the Effect of a Single Nighttime Administration of Zolpidem, Silenor and Placebo on Arousability, Ataxia/Balance and Cognitive Performance in Healthy Volunteers.

Currax Pharmaceuticals·interventional·Posted Feb 2, 2015·Updated Jan 2, 2018

In Brief

A Phase 4 clinical trial evaluating Silenor 6 mg, zolpidem 10 mg, and 1 other intervention for Healthy. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsHenry Ford Hospital

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2, 2015
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.4 years ago

Interventions

Silenor 6 mgdrug

Silenor 6 mg single nighttime dose.

zolpidem 10 mgdrug

Zolpidem 10 mg single nighttime dose

Placebodrug

placebo single nighttime dose-1.5 hours

Placebodrug

placebo single nighttime dose-4 hours