Aripiprazole Oral Acceptability Trial

Aripiprazole Oral Acceptability Trial

Sponsors

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborator: Otsuka America Pharmaceutical

Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Brief Summary

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

Overall Status Completed
Start Date March 2004
Completion Date March 2005
Primary Completion Date March 2005
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
acceptability
Enrollment 59
Condition
Intervention

Intervention type: Drug

Intervention name: Aripiprazole

Description: Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).

Arm group label: A1

Other name: Abilify

Intervention type: Drug

Intervention name: Aripiprazole

Description: Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).

Arm group label: A2

Other name: Abilify

Eligibility

Criteria:

Inclusion Criteria:

- Stable patients currently receiving aripiprazole or other antipsychotic medications.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Location
facility
Local Institution | Anaheim, California, United States
Local Institution | National City, California, United States
Local Institution | North Miami Beach, Florida, United States
Local Institution | Overland Park, Kansas, United States
Local Institution | Staten Island, New York, United States
Local Institution | Oklahoma City, Oklahoma, United States
Local Institution | Falls Church, Virginia, United States
Location Countries

United States

Verification Date

July 2008

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A1

Arm group type: Experimental

Arm group label: A2

Arm group type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov