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An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)

NCT00878462 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2024-08-15

No results posted yet for this study

Summary

This trial was a randomized trial to determine a patient's acceptability of unflavored antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients received 6 total doses of study drug (2 doses of each asenapine formulation) over 3 consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening. The formulations were: white unflavored, white raspberry flavored, and red raspberry flavored. Patients were given a questionnaire following each dose of study medication (one questionnaire twice per day for 3 days) to measure how acceptable each formulation was.

Conditions

Interventions

DRUG

Asenapine WHITE raspberry flavor (Treatment A)

Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets

DRUG

Asenapine RED raspberry flavor (Treatment B)

Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets

DRUG

Asenapine WHITE UNFLAVORED (Treatment C)

Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-29
Primary Completion
2005-10-15
Completion
2005-10-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878462 on ClinicalTrials.gov