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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)

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ClinicalTrials.gov Identifier: NCT01101464
Recruitment Status : Completed
First Posted : April 12, 2010
Results First Posted : October 13, 2010
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Schizophrenia
Schizoaffective Disorder
Interventions Drug: Asenapine 3x5mg followed by 1x15mg
Drug: Asenapine 1x15mg followed by 3x5mg
Enrollment 8
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Asenapine, (3) 5mg Then (1) 15 mg Asenapine, (1) 15 mg Then (3) 5 mg
Hide Arm/Group Description 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. 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.
Period Title: Day 1 Through AM Dose of Day 5
Started 4 4
Completed 4 4
Not Completed 0 0
Period Title: PM Dose of Day 5 Through AM Dose of Day7
Started 4 4
Completed 4 4
Not Completed 0 0
Arm/Group Title Asenapine, (3) 5 mg Then (1) 15 mg Asenapine, (1) 15 mg Then (3) 5 mg Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
1
  25.0%
1
  25.0%
2
  25.0%
Male
3
  75.0%
3
  75.0%
6
  75.0%
1.Primary Outcome
Title 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)
Hide Description

The primary objective is to compare the bioavailability using 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

Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.

Time Frame Day 5 & Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in both treatment comparisons (as per cross over design).
Arm/Group Title Asenapine 3x5mg Asenapine 1x15mg
Hide Arm/Group Description:
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
6.89  (3.08) 6.38  (2.76)
2.Primary Outcome
Title 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)
Hide Description

The primary objective is to compare the bioavailability using 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.

Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2

Time Frame Day 5 & Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in both treatment comparisons (as per cross over design).
Arm/Group Title Asenapine 3x5mg Asenapine 1x15mg
Hide Arm/Group Description:
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
Overall Number of Participants Analyzed 8 8
Mean (Full Range)
Unit of Measure: Hours
1.25
(0.5 to 2.0)
1.00
(0.5 to 3.0)
3.Primary Outcome
Title 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)
Hide Description

The primary objective is to compare the bioavailability using 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.

Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.

Time Frame Day 5 & Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in both treatment comparisons (as per cross over design).
Arm/Group Title Asenapine 3x5mg Asenapine 1x15mg
Hide Arm/Group Description:
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant).
One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant).
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
41.3  (18.2) 41.1  (17.1)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Asenapine, (3) 5 mg Then (1) 15 mg Asenapine, (1) 15 mg Then (3) 5 mg
Hide Arm/Group Description 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 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.
All-Cause Mortality
Asenapine, (3) 5 mg Then (1) 15 mg Asenapine, (1) 15 mg Then (3) 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Asenapine, (3) 5 mg Then (1) 15 mg Asenapine, (1) 15 mg Then (3) 5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Asenapine, (3) 5 mg Then (1) 15 mg Asenapine, (1) 15 mg Then (3) 5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      3/4 (75.00%)    
Gastrointestinal disorders     
Dyspepsia  1  1/4 (25.00%)  1 1/4 (25.00%)  1
Nervous system disorders     
Extrapyramidal disosrder  1  1/4 (25.00%)  1 1/4 (25.00%)  1
Psychiatric disorders     
Anxiety  1  1/4 (25.00%)  1 1/4 (25.00%)  1
Insomnia  1  1/4 (25.00%)  1 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.0)
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.
All publications must be based on data validated by Organon. Any such communication will first be submitted to Organon, at least 6 weeks ahead of time for written consent. Organon shall have the right to make its consent conditional upon proper representation of the interpretation of both Organon and the investigator. In any communication concerning this trial, the authors of this protocol will be included in the list of authors.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01101464     History of Changes
Other Study ID Numbers: P05937
First Submitted: March 3, 2010
First Posted: April 12, 2010
Results First Submitted: June 3, 2010
Results First Posted: October 13, 2010
Last Update Posted: November 2, 2015