At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 930 enrolled
Drug / intervention
Circadin +1 moredrug
Likely dose
Circadin 2 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.
A Double-blind, Parallel Group, Randomised, Placebo Controlled Study of Efficacy and Safety of Circadin® 2 mg in the Treatment of Insomnia Patients With Low Endogenous Melatonin
In Brief
A Phase 3 clinical trial evaluating Circadin and placebo circadin for Primary Insomnia. Completed, enrolled 930 participants across 1 site.
Detailed Summary
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Insomnia
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedNov 2006
Primary CompletionDec 2008
Study CompletionApr 2009
TodayJul 2026
First PostedNov 8, 2006
Enrollment StartOct 1, 2006
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.7 years ago
Interventions
Circadindrug
Prolonged release melatonin 2 mg
placebo circadindrug
placebo circadin tablets