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Last Updated: April 27, 2024

CLINICAL TRIALS PROFILE FOR FAZACLO ODT


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All Clinical Trials for FAZACLO ODT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00501618 ↗ Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder Completed Azur Pharma, Inc Phase 4 2006-11-01 The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.
NCT00501618 ↗ Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder Completed Manhattan Psychiatric Center Phase 4 2006-11-01 The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.
NCT00683891 ↗ FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey Completed Azur Pharma, Inc 1969-12-31 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.
NCT02286206 ↗ Study of the Effect of Dosing on Clozapine Levels Withdrawn University of British Columbia Phase 4 2015-01-01 The objectives of this 15-day study are: 1. To compare steady-state trough plasma concentrations of clozapine and its metabolite norclozapine when given once daily and twice daily (at the same total daily dose) 2. To determine if frequency of clozapine administration has an effect on: 1. Symptoms of schizophrenia 2. Adverse effects of clozapine 3. Fasting blood glucose, lipids, creatinine, and urea 4. Weight and waist circumference
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FAZACLO ODT

Condition Name

Condition Name for FAZACLO ODT
Intervention Trials
Schizophrenia 2
Psychotic Disorders 1
Schizoaffective Disorder 1
Sialorrhea 1
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Condition MeSH

Condition MeSH for FAZACLO ODT
Intervention Trials
Schizophrenia 3
Psychotic Disorders 2
Disease 1
Mental Disorders 1
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Clinical Trial Locations for FAZACLO ODT

Trials by Country

Trials by Country for FAZACLO ODT
Location Trials
United States 3
Canada 1
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Trials by US State

Trials by US State for FAZACLO ODT
Location Trials
North Carolina 1
California 1
New York 1
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Clinical Trial Progress for FAZACLO ODT

Clinical Trial Phase

Clinical Trial Phase for FAZACLO ODT
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for FAZACLO ODT
Clinical Trial Phase Trials
Completed 2
Withdrawn 1
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Clinical Trial Sponsors for FAZACLO ODT

Sponsor Name

Sponsor Name for FAZACLO ODT
Sponsor Trials
Azur Pharma, Inc 2
Manhattan Psychiatric Center 1
University of British Columbia 1
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Sponsor Type

Sponsor Type for FAZACLO ODT
Sponsor Trials
Industry 2
Other 2
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