A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937 Am1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01101464
First received: March 3, 2010
Last updated: April 30, 2014
Last verified: April 2014
Results First Received: June 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Asenapine 3x5mg followed by 1x15mg
Drug: Asenapine 1x15mg followed by 3x5mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects rec'd asenapine 5mg BID on Day 1 & 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.

Reporting Groups
  Description
Asenapine, (3) 5mg Then (1) 15 mg Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
Asenapine, (1) 15 mg Then (3) 5 mg One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.

Participant Flow for 2 periods

Period 1:   Day 1 Through AM Dose of Day 5
    Asenapine, (3) 5mg Then (1) 15 mg     Asenapine, (1) 15 mg Then (3) 5 mg  
STARTED     4     4  
COMPLETED     4     4  
NOT COMPLETED     0     0  

Period 2:   PM Dose of Day 5 Through AM Dose of Day7
    Asenapine, (3) 5mg Then (1) 15 mg     Asenapine, (1) 15 mg Then (3) 5 mg  
STARTED     4     4  
COMPLETED     4     4  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Asenapine, (3) 5 mg Then (1) 15 mg Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
Asenapine, (1) 15 mg Then (3) 5 mg One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
Total Total of all reporting groups

Baseline Measures
    Asenapine, (3) 5 mg Then (1) 15 mg     Asenapine, (1) 15 mg Then (3) 5 mg     Total  
Number of Participants  
[units: participants]
  4     4     8  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     4     8  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     3     3     6  



  Outcome Measures
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1.  Primary:   Pharmacokinetic Parameter of Maximum Plasma Concentration (Cmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)   [ Time Frame: Day 5 & Day 7 ]

2.  Primary:   Pharmacokinetic Parameter of Time of Occurrence of Cmax (Tmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)   [ Time Frame: Day 5 & Day 7 ]

3.  Primary:   Pharmacokinetic Parameter of Area Under the Curve (AUC) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)   [ Time Frame: Day 5 & Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01101464     History of Changes
Other Study ID Numbers: P05937
Study First Received: March 3, 2010
Results First Received: June 3, 2010
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration