Schizophrenia Clinical Trial
| NCT number | NCT00094640 |
| Other study ID # | 6106 |
| Secondary ID | F1D-EW-LOBS |
| Status | Completed |
| Phase | Phase 1 |
| First received | October 21, 2004 |
| Last updated | July 18, 2006 |
| Verified date | July 2006 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The goals of this study are to:
Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different
points in time after an injection, and compare these levels to the amount of olanzapine in
the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets
or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 76 Years |
| Eligibility |
Inclusion Criteria: - Patients must have schizophrenia or schizoaffective disorders. - Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent. - Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry. - Female patients must not be pregnant or breast-feeding. - Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or schizoaffective disorder. |
Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Adelaide | South Australia |
| Belgium | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Kortenberg | |
| Brazil | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Rio De Janeiro | RJ |
| Croatia | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Zagreb | |
| Czech Republic | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Praha 8 | |
| Mexico | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Mexico City | Tlalpan |
| Slovakia | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Bratislava | |
| Spain | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Australia, Belgium, Brazil, Croatia, Czech Republic, Mexico, Slovakia, Spain,
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