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

NCT ID: NCT00324051

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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olanzapine therapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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.

Constanța, , Romania

Site Status

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 (Türkiye)

Site Status

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 (Türkiye)

Site Status

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 (Türkiye)

Site Status

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.

Elâzığ, , Turkey (Türkiye)

Site Status

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 (Türkiye)

Site Status

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 (Türkiye)

Site Status

Countries

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Brazil Romania Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 20653494 (View on PubMed)

Other Identifiers

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F1D-VI-S067

Identifier Type: OTHER

Identifier Source: secondary_id

10960

Identifier Type: -

Identifier Source: org_study_id

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