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Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

NCT00397189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2018-05-01

Study results available
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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.

Conditions

  • Primary Insomnia

Interventions

DRUG

Circadin

Prolonged release melatonin 2 mg

DRUG

placebo circadin

placebo circadin tablets

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Gordon M Crawford, MBChB · CPS Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00397189 on ClinicalTrials.gov