AzTrials
AzTrials

SchizophreniaPhase 3NCT00136994

IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 34 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Ziprasidone
How many people
160 participants
Where
34 sitesItaly
Study dates
Mar 2003to Nov 2005
Phase
Phase 3
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Psychiatric:
  • Diagnosis of schizophrenia using DSM-IV (295.xx).
  • Patients entering hospital (or inpatients transferring to higher-dependency unit) within the previous seven days because of acute exacerbation of psychotic symptoms.
  • PANSS > 80 (score ³ 3 on at least three of the following PANSS agitation items: anxiety , tension, hostility, excitement).
  • CGI-S ³ 4. - Indication, based on intensity/severity of psychotic symptoms, on IM therapy.
  • General:
Show all 9Show fewer
  • Male or Female patients aged 18-60 years at screening.
  • Written informed consent to participation.
  • Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception can be initiated or continued.

Who cannot join

  • Psychiatric:
  • Patients at immediate risk of committing harm to self or others
  • Concurrent treatment with other antipsychotic agents after baseline
  • Patients receiving depot antipsychotic medication within 21 days of screening
  • Treatment with antidepressants or mood stabilizers (such as lithium, carbamazepine, valproic acid or verapamil) within two weeks of screening
  • Diagnosis of substance abuse using DSM-IV criteria within previous 12 months
Show all 25Show fewer
  • Positive urine drug screen at screening for amphetamine, cocaine or opioids
  • Alcohol and/or any other drug abuse at screening
  • Patients who have received clozapine within 3 months prior to screening due to intolerance to other antipsychotics or patients who have received clozapine in the past two years for refractoriness to treatment
  • Treatment with any investigational agent within the previous six months
  • Previous treatment with ziprasidone
  • Organic mental disease, including mental retardation
  • History of psychosurgery
  • General:
  • Patients with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only patients with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study - Patients with a history of significant cardiovascular disease or significant concurrent cardiovascular disease, including a history of uncontrolled hypertension (supine diastolic pressure >95 mm Hg and/or supine systolic pressure > 170 mm Hg with or without treatment)
  • Clinically significant ECG abnormality
  • Patient with QTc ³ 450 msec - Concomitant treatment with medications that prolong QT interval
  • Patients with serum K+ or Mg++ outside the normal range
  • Confirmed clinically significant laboratory values.
  • Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times the normal limits)
  • Patients who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
  • Patients unable or unlikely to follow the study protocol
  • Pregnant or lactating women
  • Patients with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
  • Known hypersensitivity to ziprasidone or lactose

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Italy34 sites

  • Pfizer Investigational Site

    Bologna, 40100

  • Pfizer Investigational Site

    Cagliari, 09100

  • Pfizer Investigational Site

    Campi Bisenzio, Firenze, 50013

  • Pfizer Investigational Site

    Caserta, 81100

  • Pfizer Investigational Site

    Chiari (BS), 25032

  • Pfizer Investigational Site

    Cremona, 26100

  • Pfizer Investigational Site

    Fidenza(pr), 43036

  • Pfizer Investigational Site

    Foggia, 71100

  • Pfizer Investigational Site

    Genova, 16132

  • Pfizer Investigational Site

    Genova-sestri, 16154

  • Pfizer Investigational Site

    Lecce, 73100

  • Pfizer Investigational Site

    Milan, 20142

  • Pfizer Investigational Site

    Modena, 41100

  • Pfizer Investigational Site

    Moncalieri(to), 10024

  • Pfizer Investigational Site

    Naples, 80136

  • Pfizer Investigational Site

    Noto, 96017

  • Pfizer Investigational Site

    Orbassano (TO), 10043

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Palermo, 90145

  • Pfizer Investigational Site

    Parma, PR, 43100

  • Pfizer Investigational Site

    Perugia, 06100

  • Pfizer Investigational Site

    Pordenone, 33170

  • Pfizer Investigational Site

    Roma, 00149

  • Pfizer Investigational Site

    S. Arsenio, Salerno, 84037

  • Pfizer Investigational Site

    Sassari, 07100

  • Pfizer Investigational Site

    Savigliano, Cuneo, 12038

  • Pfizer Investigational Site

    Senigallia (AN), 60019

  • Pfizer Investigational Site

    Sora, Frosinone, 3039

  • Pfizer Investigational Site

    Torino, 10126

  • Pfizer Investigational Site

    Torino, 10154

  • Pfizer Investigational Site

    Torrette DI Ancona (AN), 60020

  • Pfizer Investigational Site

    Udine, 33100

  • Pfizer Investigational Site

    Verona, 37063

  • Pfizer Investigational Site

    Viareggio, 55049

Other trials in Italy

About this study

Official title: An Open Trial to Evaluate the Efficacy and Tolerability of Ziprasidone IM and Oral in Patients With Psychosis and Acute Agitation.

To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia

Conditions
Schizophrenia
Being tested
Ziprasidone
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiprasidoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2005 (estimated)
  2. Study startMar 2003
  3. Study completionNov 2005

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00136994
Sponsor's protocol ID
A1281045
Status last verified
Feb 2021
First submitted
25 Aug 2005
Last updated
21 Feb 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 34 sites in Italy.

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 9 inclusion and 25 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Italy. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00136994.

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 21 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in