Lendormin D® Tablet (Drug Use Result Survey)

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Lendormin D tablets

• Registration Number: NCT02224014
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate the safety and the efficacy in patients with insomnia, receiving Lendormin D tablet under condition of normal clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

• Patients with insomnia

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lendormin D tablets	Lendormin D tablets	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 2 months
Number of patients with serious adverse events	up to 2 months
Number of patients with adverse drug reactions	up to 2 months

Secondary Outcome Measures

Name	Time	Method
Physician's overall efficacy assessment on a 3-point scale	up to 2 months
Patient's impression questionnaire	up to 2 months