Aripiprazole Oral Acceptability Trial

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.
The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States
        • Local Institution
      • National City, California, United States
        • Local Institution
    • Florida
      • North Miami Beach, Florida, United States
        • Local Institution
    • Kansas
      • Overland Park, Kansas, United States
        • Local Institution
    • New York
      • Staten Island, New York, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
    • Virginia
      • Falls Church, Virginia, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable patients currently receiving aripiprazole or other antipsychotic medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Drug: Aripiprazole
Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
Other Names:
  • Abilify
Drug: Aripiprazole
Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
Other Names:
  • Abilify
Experimental: A2
Drug: Aripiprazole
Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
Other Names:
  • Abilify
Drug: Aripiprazole
Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
acceptability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

January 12, 2005

First Submitted That Met QC Criteria

January 12, 2005

First Posted (Estimate)

January 13, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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