Status:
COMPLETED
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.
Eligibility Criteria
Inclusion
- Psychophysiologic insomnia
- Severity: mild to moderate
- Duration: subacute to chronic
- Subjects age \> 18 and \< 65, men or women
- Subject had to give written informed consent
Exclusion
- Regular use of psycho-active drugs
- Work in shifts
- Use of psychoactive drugs during the past 30 days
- Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
- known hypersensitivity to any of the ingredients of the study drug
- Pregnancy, lactation, women of childbearing potential not using an established contraceptive
- Drug and alcohol abuse
- Participation in another trial within the past 30 days
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT02183714
Start Date
May 1 1998
Last Update
July 8 2014
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