An Observational Study of Olanzapine Coated and Orodisper... | NCT00510211

Studies
An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

NCT00510211

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Aug 3, 2009Estimated

Enrollment

1,131Actual

Phase

Not provided

Conditions

Schizophrenia
Bipolar Disorder

Interventions

olanzapine

Countries

France
Germany
Greece

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

ID	Type	Description	Link
F1D-FR-B035

Status Module

Record Verification Date

Jul 2009

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

Apr 2007

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Jul 30, 2007

First Submission Date that Met QC Criteria

Jul 30, 2007

First Posted Date

Aug 1, 2007Estimated

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

Jul 31, 2009

Last Update Posted Date

Aug 3, 2009Estimated

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

Description Module

Brief Summary

The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings

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

Not provided

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

1,131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
olanzapine coated tablet			Drug: olanzapine
olanzapine orodispersable tablet			Drug: olanzapine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olanzapine	Drug		olanzapine coated tablet olanzapine orodispersable tablet

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients suffering from schizophrenic or schizoaffective disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days.
patients suffering from bipolar disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days for one of the following:
moderate or severe manic episode
relapse prevention in patients with bipolar disorder

Exclusion Criteria:

current treatment with any investigational drug or procedure at entry or during the whole study
hypersensitivity to olanzapine
patients with known narrow angle glaucoma risk

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients observed in outpatient settings (ambulatory and community)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Paris		75674

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077152	Olanzapine

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided