Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet

Schizophrenia Clinical Trial

— PREFERENCE  

Official title:

PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324051
• Other study ID #: 10960
• Secondary ID: F1D-VI-S067
• Status: Completed
• Phase: Phase 4
• Start date: May 2006
• Est. completion date: September 2007

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to estimate drug preference of stable schizophrenic patients who will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine tablets for 6 weeks and vice-versa.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• You are an outpatient diagnosed with stable schizophrenia.

• You are a male or female in the age of 18 to 65 years old.

• You are retrospectively judged by investigators, based on clinical interview and impression, to have been stable for at least 4 weeks.

• You must be able to take olanzapine orodispersible in a single daily dose.

• You are treated with conventional oral olanzapine tablet (as monotherapy) for at least 1 month.

Exclusion Criteria:

• You have used olanzapine in the past and are no longer using it because of a bad reaction.

• You have known Human immunodeficiency virus positive (HIV+) status.

• You have known uncorrected, narrow angle glaucoma.

• You have known Leukopenia, (abnormally low white blood cell count).

• You have a serious or uncontrolled illness (for example: liver disease, history of heart disease, or inadequately controlled diabetes.)

• You have Parkinson's disease.

• You are a female patient who is either pregnant or nursing

• You are taking medications that are not allowed in the study.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• olanzapine therapy

Locations

Country	Name	City	State
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rio De Janeiro
Romania	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Constanta
Turkey	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Adana
Turkey	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ankara
Turkey	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bursa
Turkey	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Elazig
Turkey	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gaziantep
Turkey	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Brazil,  Romania,  Turkey, 

References & Publications (1)

Bitter I, Treuer T, Dilbaz N, Oyffe I, Ciorabai EM, Gonzalez SL, Ruschel S, Salburg J, Dyachkova Y. Patients' preference for olanzapine orodispersible tablet compared with conventional oral tablet in a multinational, randomized, crossover study. World J B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient preference measured by a simple preference question.
Secondary	Better treatment adherence as measured by DAI-10
Secondary	Safety and tolerability as measured by AMDP-5
Secondary	Determine the predictors of drug compliance
Secondary	Mean change from baseline to endpoint in body mass index (BMI)
Secondary	Compare serum ghrelin levels
Secondary	Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)
Secondary	Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)
Secondary	Patient preference of the paranoid sub population as measured by a simple preference question

External Links

•   Lilly Clinical Trial Registry