Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00368056
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 55 years inclusive
* In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
* Diagnostic and statistical manual of mental disorders, defined primary insomnia
* A body mass index greater than or equal to 18 and less than or equal to 30
* Registered with a general practitioner (GP)
* Hold a full current driving licence for at least one year, and be regular car drivers
Exclusion Criteria
* The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
* Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
* Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
* Any subject with known hypersensitivity to any of the study treatments
* A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
* Pregnant or lactating females, and females of child bearing potential not using effective contraception
* Patients who habitually smoke more than 5 cigarettes per day
* Caffeine consumption of more than 5 cups or glasses per day
* History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
* Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00368056
Study Brief:
Protocol Section:
NCT00368056