Lendormin D® Tablet (Drug Use Result Survey) | NCT02224014

Studies
Lendormin D® Tablet (Drug Use Result Survey)

NCT02224014

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Aug 22, 2014Estimated

Enrollment

485Actual

Phase

Not provided

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Lendormin D tablets

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Aug 21, 2014

First Submission Date that Met QC Criteria

Aug 21, 2014

First Posted Date

Aug 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 22, 2014Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

485Actual

Label	Type	Description	Intervention Names
Lendormin D tablets			Drug: Lendormin D tablets

Name	Type	Description	Arm Group Labels	Other Names
Lendormin D tablets	Drug		Lendormin D tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events		up to 2 months
Number of patients with adverse drug reactions		up to 2 months
Number of patients with serious adverse events		up to 2 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with insomnia

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with insomnia, receiving Lendormin D tablet under condition of normal clinical practice

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided