FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey

This study has been completed.

Sponsor:

Information provided by:

Azur Pharma, Inc

ClinicalTrials.gov Identifier:

NCT00683891

First received: May 22, 2008

Last updated: June 18, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	May 22, 2008
Last Updated Date	June 18, 2008
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: May 23, 2008)	Clinical changes in body weight in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo Clinical changes in salivation in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00683891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 23, 2008)	Changes in Clinical Global Impression (CGI) scale when compared to baseline
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey
Official Title ^ICMJE	FazaClo Outcomes in the Control of Schizophrenia (FOCUS)
Brief Summary	AZUR Pharma has received several reports from practicing psychiatrists prescribing FazaClo showing that FazaClo patients start losing body weight instead of keep gaining it, after being switched from other clozapine products or other atypical antipsychotics treatments. Another important clinical observation reported by doctors is a considerable reduction in hypersalivation when FazaClo administration is compared to other antipsychotic treatments. Based on the findings described above, and on the real need for effective and safer treatments for schizophrenia, AZUR Pharma has decided to design and conduct an observational study in a large number of patients taking FazaClo to prove the received clinical reports from physicians. Better understanding and evaluation of these beneficial findings are necessary to provide physicians information for improved treatment decision.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The enrolled population consists of male and female patients with treatment-resistant schizophrenia of 18 years of age or older, already taking Clozaril (clozapine) or generic clozapine, or patients with treatment-resistant schizophrenia who have failed on other atypical antipsychotic drugs.
Condition ^ICMJE	Weight Gain Sialorrhea
Intervention ^ICMJE	Drug: FazaClo (clozapine, USP) ODT
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with treatment-resistant schizophrenia currently being treated with Clozaril or generic clozapine for at least 3 months Patients with treatment-resistant schizophrenia who failed to respond adequately to treatment with at least 2 courses of standard drug treatments for schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs Males and females of 18 years of age or older Females of childbearing potential using a reliable form of contraception Ability to comply with the required WBC/ANC monitoring schedule Ability to follow physician's instructions Signed informed consent by patient or legal guardian Exclusion Criteria: Phenylketonurics Females of childbearing potential not using a reliable form of contraception Women who are pregnant or want to become pregnant Nursing Patients allergic to clozapine or any othe ingredient contained in FazaClo tablets Patients who have previously experienced a severe adverse reaction to clozapine Patients previously excluded from taking clozapine due to a higher risk of developing white blood cell disorders Clinical significant medical condition that the physician believes may increase the patient's risk of participating int he study (e.g., severe cardiac disorder, epilepsy) Concomitant medications that may be contraindicated with FazaClo Patients who have been taking FazaCLo within the last three months Patients unable to comply with the required WBC/ANC monitoring schedule Patients unable to follow the physician's instructions Patients unable or unwilling to provide Informed Consent
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00683891
Other Study ID Numbers ^ICMJE	FOCUS
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Azur Pharma, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Azur Pharma, Inc
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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