Back to resultsPatient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet (PREFERENCE)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
olanzapine therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Outcomes
Primary Outcome Measures
Patient preference measured by a simple preference question.
Secondary Outcome Measures
Better treatment adherence as measured by DAI-10
Safety and tolerability as measured by AMDP-5
Determine the predictors of drug compliance
Mean change from baseline to endpoint in body mass index (BMI)
Compare serum ghrelin levels
Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)
Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)
Patient preference of the paranoid sub population as measured by a simple preference question
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00324051
Brief Title
Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet
Acronym
PREFERENCE
Official Title
PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
olanzapine therapy
Primary Outcome Measure Information:
Title
Patient preference measured by a simple preference question.
Secondary Outcome Measure Information:
Title
Better treatment adherence as measured by DAI-10
Title
Safety and tolerability as measured by AMDP-5
Title
Determine the predictors of drug compliance
Title
Mean change from baseline to endpoint in body mass index (BMI)
Title
Compare serum ghrelin levels
Title
Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)
Title
Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)
Title
Patient preference of the paranoid sub population as measured by a simple preference question
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Rio De Janeiro
ZIP/Postal Code
21020-130
Country
Brazil
Facility Name
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.
City
Constanta
Country
Romania
Facility Name
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.
City
Adana
Country
Turkey
Facility Name
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.
City
Ankara
Country
Turkey
Facility Name
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.
City
Bursa
ZIP/Postal Code
16045
Country
Turkey
Facility Name
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.
City
Elazig
ZIP/Postal Code
23800
Country
Turkey
Facility Name
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.
City
Gaziantep
Country
Turkey
Facility Name
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.
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
20653494
Citation
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 Biol Psychiatry. 2010 Oct;11(7):894-903. doi: 10.3109/15622975.2010.505663.
Results Reference
result
Learn more about this trial
Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet
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