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A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00316238
First received: April 18, 2006
Last updated: June 6, 2007
Last verified: June 2007

April 18, 2006
June 6, 2007
April 2006
Not Provided
To evaluate dose-response relationship and to confirm the efficacy of IM olanzapine by sequentially comparing each of IM olanzapine groups and IM placebo group with respect to the changes from baseline to 2 hours post first IM injection of agitation.
Same as current
Complete list of historical versions of study NCT00316238 on ClinicalTrials.gov Archive Site
  • To determine if the efficacy of IM olanzapine is greater than IM placebo by evaluating sequentially comparing changes at 30 min, 60 min, 90 min post first IM injection of agitation, as measured by the PANSS-EC in schizophrenia patients.
  • To determine if the efficacy of IM olanzapine groups are greater than the IM placebo by evaluating sequentially changes from baseline to 2 hours post first IM injection in the rate of responder, CGI-I, and ACES.
  • To examine whether a dose-response relationship exists for IM olanzapine in higher agitation, by using mean changes of PANSS-EC total score from baseline to 2 hours post first IM injection as measured by PANSS-EC (Score total no less than 20).
  • To compare the efficacy of IM olanzapine(2.5, 5, 7.5, or 10 mg) to IM placebo by evaluating sequentially changes from baseline to 24 hours post first IM injection in the PANSS-EC, CGI-S, Clinical Global Impression-Improvement of Illness (CGI-), and ACES.
  • To compare efficacy of IM olanzapine(2.5, 5, 7.5, or 10 mg)to IM placebo in the frequency of patients who need second injection and time to second injection.
  • To compare the safety of IM olanzapine groups to IM placebo group over a 24 hours period in terms of ACES, TEAE, changes in laboratory values, pulse, blood pressure, ECG, DIEPSS.
Same as current
Not Provided
Not Provided
 
A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
A Double-Blind Dose-Response Study Comparing Rapid Acting Intramuscular Olanzapine and Intramuscular Placebo in Agitated Patients With Schizophrenia

To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients with Schizophrenia

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
  • Drug: olanzapine-RAIM
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2007
Not Provided

Inclusion Criteria:

  • Patients must have schizophrenia that meets disease diagnostic criteria in DSM-IV-TR
  • Patients must be inpatients during the study
  • Patients must have a minimum total score of no less than 14 on the five items of the PANSS-EC and at least one individual item score of no less than 4 using the 1-7 scoring system prior to the first injection of study drug

Exclusion Criteria:

  • Patients who have a known history of diabetes mellitus.
  • Patients who have received treatment with antipsychotics or other prohibited concomitant medicines within 2 hours prior to the first IM study drug administration
  • Patients who have had treatment with benzodiazepines within 4 hours prior to first IM study drug administration.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00316238
5294, F1D-JE-RA02
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP