Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet (PREFERENCE)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00324051
First received: May 8, 2006
Last updated: January 21, 2008
Last verified: January 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: olanzapine therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
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
| Estimated Enrollment: | 284 |
| Study Start Date: | May 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324051
Locations
| 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, Brazil, 21020-130 | |
| 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, Romania | |
| 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, 16045 | |
| 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, 23800 | |
| 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, Turkey, 34390 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00324051 History of Changes |
| Other Study ID Numbers: | 10960, F1D-VI-S067 |
| Study First Received: | May 8, 2006 |
| Last Updated: | January 21, 2008 |
| Health Authority: | Israel: Ethics Commission Brazil: National Committee of Ethics in Research Romania: State Institute for Drug Control Turkey: Ministry of Health Mexico: Ministry of Health Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013