The Effectiveness of Circadin in Improving Quality of Sle... | NCT02321449

Studies
The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

NCT02321449

Sponsor

Ipsen

Status

Completed

Last Update Posted

Jan 11, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Insomnia

Interventions

Not provided

Countries

Russia

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

Jan 2019

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 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Dec 17, 2014

First Submission Date that Met QC Criteria

Dec 19, 2014

First Posted Date

Dec 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

Jan 10, 2019

Last Update Posted Date

Jan 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in quality of sleep questionnaire	Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.	Baseline, 3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in attention Questionnaire		Baseline, 3 weeks
Change from baseline in memory Questionnaire		Baseline, 3 weeks
Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
Patients able to follow the study protocol
Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
Patients who have just been identified to receive treatment with Circadin
Patients without previous treatment with Circadin

Exclusion Criteria:

Hypersensitivity to any components of Circadin
Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
Pregnancy and lactation
Alcohol or drug addiction
Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
Intake of psychoactive medicines within the last 30 days before observational study entry
Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale
Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult male and female patients aged ≥ 55 years suffering from primary (non-organic) insomnia characterized by poor quality of sleep

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
State research center of preventive medicine		Moscow		101000	Russia
Research and Education Center of Moscow State University named after M.V. Lomonosov

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