SchizophreniaPhase 4NCT02137993
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
A Phase 4 study testing A-prexa and Zyprexa in people with Schizophrenia and Schizophreniform Disorder, run by HK inno.N Corporation.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- A-prexa and Zyprexa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years to 65 years
- Schizophrenia patient with an acute exacerbation
- Understand the requirement of the study and voluntarily consent to participate in the study
Who cannot join
- Patients who have another psychiatric disorders
- Patients who have unstable medical conditions
- Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit
- Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
- Patients who have a history of an allergic reaction to olanzapine
- Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
- Patient who take clozapine within 12 weeks before screening visit
About this study
Official title: A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder
The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.
- Being tested
- A-prexa, Zyprexa
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-prexaDrug
A-prexa 5-20 mg for 6 weeks
ZyprexaDrug
Zyprexa 5-20 mg for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| A-prexa | Experimental | A-prexa 5, 10mg Receives: Drug: Zyprexa |
| Zyprexa | Active comparator | Zyprexa 5, 10mg Receives: Drug: A-prexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 6 week in total PANSS score
Measured: 6 week
Secondary outcomes (4)
Change from baseline at 1, 2, 4 and 6 week in total PANSS score.
Measured: 6 week
Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week
Measured: 6 week
Change from baseline at 6 week in total CGI-S score
Measured: 6 week
Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137993
- Sponsor's protocol ID
- CJ_OLZ_401
- Status last verified
- May 2014
- First submitted
- 11 May 2014
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02137993
- Acronym / sponsor ID
- CJ_OLZ_401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 May 2014 (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.
The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-prexa | Experimental | Drug: ZyprexaA-prexa 5, 10mg |
| Zyprexa | Active comparator | Drug: A-prexaZyprexa 5, 10mg |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 years to 65 years
- Schizophrenia patient with an acute exacerbation
- Understand the requirement of the study and voluntarily consent to participate in the study
Key exclusion criteria (7 listed)
- Patients who have another psychiatric disorders
- Patients who have unstable medical conditions
- Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit
- Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
- Patients who have a history of an allergic reaction to olanzapine
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 |
|---|---|---|
| A-prexaA-prexa 5-20 mg for 6 weeks | Drug | Zyprexa |
| ZyprexaZyprexa 5-20 mg for 6 weeks | Drug | A-prexa |
Primary outcome
Change from baseline at 6 week in total PANSS score
Time frame: 6 week
4 secondary outcomes
Change from baseline at 1, 2, 4 and 6 week in total PANSS score.
Time frame: 6 week
Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week
Time frame: 6 week
Change from baseline at 6 week in total CGI-S score
Time frame: 6 week
Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'
Time frame: 6 week
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 14 May 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A-prexa and Zyprexa in people with Schizophrenia and Schizophreniform Disorder, run by HK inno.N Corporation.
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 3 inclusion and 7 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline at 6 week in total PANSS score (time frame: 6 week). 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 14 May 2014.