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Aripiprazole Oral Acceptability Trial

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stable patients currently receiving aripiprazole or other antipsychotic medications.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A1

A2

Arm Description

Outcomes

Primary Outcome Measures

acceptability

Secondary Outcome Measures

Full Information

First Posted
January 12, 2005
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00101569
Brief Title
Aripiprazole Oral Acceptability Trial
Official Title
Aripiprazole Oral Acceptability Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (false)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Title
A2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
Primary Outcome Measure Information:
Title
acceptability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable patients currently receiving aripiprazole or other antipsychotic medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Anaheim
State/Province
California
Country
United States
Facility Name
Local Institution
City
National City
State/Province
California
Country
United States
Facility Name
Local Institution
City
North Miami Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Local Institution
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Falls Church
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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Aripiprazole Oral Acceptability Trial

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