Weight GainFOCUSNCT00683891
FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey
An observational study of Weight Gain and Sialorrhea, run by Azur Pharma, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Gain, Sialorrhea
- What is being tested?
- FazaClo (clozapine, USP) ODT
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pacific Neuropsychiatric Specialists
Costa Mesa, California, 92626
Gihwala & Associates
Gastonia, North Carolina, 28054
About this study
Official title: FazaClo Outcomes in the Control of Schizophrenia (FOCUS)
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.
- Conditions
- Weight Gain, Sialorrhea
- Being tested
- FazaClo (clozapine, USP) ODT
- Keywords
- FOCUS, Weight gain, Sialorrhea, Treatment refractory schizophrenia, FazaClo, Treatment resistant schizophrenia, clozapine, Hypersalivation
- Medical subject headings
- Weight Gain, Sialorrhea, Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FazaClo (clozapine, USP) ODTDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
Changes in Clinical Global Impression (CGI) scale when compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Azur Pharma, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683891
- Sponsor's protocol ID
- FOCUS
- Acronym
- FOCUS
- Status last verified
- Jun 2008
- First submitted
- 22 May 2008
- Last updated
- 19 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FazaClo Outcomes in the Control of Schizophrenia (FOCUS)
- ClinicalTrials.gov ID
- NCT00683891
- Acronym / sponsor ID
- FOCUS / FOCUS
- Conditions
- Weight Gain, Sialorrhea
- Keywords
- FOCUS, Weight gain, Sialorrhea, Treatment refractory schizophrenia, FazaClo, Treatment resistant schizophrenia, clozapine, Hypersalivation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Azur Pharma, IncIndustry (pharma, biotech, devices)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FazaClo (clozapine, USP) ODT | Drug | – |
Primary outcome
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
1 secondary outcome
Changes in Clinical Global Impression (CGI) scale when compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Sialorrhea, run by Azur Pharma, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical changes in body weight in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2008.