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Asenapine WHITE raspberry flavor

Phase 2

Psychosis | Small molecule | Psychiatry |Organon & Co.|Last Updated: Aug 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment174

FDA Designations

No designations recorded

Clinical trial landscape

Asenapine WHITE raspberry flavor · 1 trial · 1 indication

Phase 2 1
NCT00878462An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)Psychosis
COMPLETED174 Analytics
PHASE2COMPLETED
An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
PsychosisUnlock trial analytics

Study Endpoints

Primary Endpoints

The response to the question: "How likely would you be to take this medication for at least 1 year if your doctor continued to prescribe it to you and it worked well?""
After each dose (morning and evening of days 1 through 3)
The response on the following question: "Considering your total impression of this tablet, like the look, the taste and the feel of the tablet, how acceptable is this tablet to you?"
After each dose (morning and evening of days 1 through 3)

Secondary Endpoints

Responses on the following question: "How acceptable was the taste of the tablet?"
After each dose (morning and evening of days 1 through 3)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALSubjects randomly assigned to this sequence receive in order: Treatment A, C, B, A, C, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days.
Sequence 2EXPERIMENTALSubjects randomly assigned to this sequence receive in order: Treatment A, B, C, A, B, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days.
Sequence 3EXPERIMENTALSubjects randomly assigned to this sequence receive in order: Treatment B, C, A, B, C, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days.
Sequence 4EXPERIMENTALSubjects randomly assigned to this sequence receive in order: Treatment B, A, C, B, A, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days.
Sequence 5EXPERIMENTALSubjects randomly assigned to this sequence receive in order: Treatment C, B, A, C, B, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days.
Sequence 6EXPERIMENTALSubjects randomly assigned to this sequence receive in order: Treatment C, A, B, C, A, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days.

Interventions

NameTypeDescription
Asenapine WHITE raspberry flavor (Treatment A)DRUGAsenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Asenapine RED raspberry flavor (Treatment B)DRUGAsenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Asenapine WHITE UNFLAVORED (Treatment C)DRUGAsenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * are at least 18 years of age and of legal minimum age for trial participation; * are a male, or a female who is not of childbearing potential * are free from an acute exacerbation of psychosis for at least 3 months; * have a current DSM-IV diagnosis of schizophrenia (paranoid,...

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Frequently asked questions about Asenapine WHITE raspberry flavor

What is Asenapine WHITE raspberry flavor used for?

Asenapine WHITE raspberry flavor is an investigational small molecule being studied for psychosis. It is a raspberry-flavored formulation of asenapine intended to improve acceptability in stable patients with a psychotic disorder. The drug is in Phase 2 clinical development and is not yet approved.

Who makes Asenapine WHITE raspberry flavor?

Asenapine WHITE raspberry flavor is being developed by Organon & Co. (NYSE: OGN). The company is conducting clinical research on this raspberry-flavored formulation of asenapine for the treatment of psychosis.

What phase is Asenapine WHITE raspberry flavor in?

Asenapine WHITE raspberry flavor is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for use in patients with psychosis.

What clinical trials is Asenapine WHITE raspberry flavor in?

Asenapine WHITE raspberry flavor has one completed Phase 2 clinical trial, NCT00878462, titled "An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)." The study enrolled 174 participants and was a controlled, randomized trial.

Is Asenapine WHITE raspberry flavor the same as asenapine?

Asenapine WHITE raspberry flavor is a raspberry-flavored formulation of asenapine, a small molecule antipsychotic. The flavoring is designed to improve patient acceptability compared to the unflavored version. The drug is being studied specifically for its acceptability in patients with psychotic disorders.