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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 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 3, 2010
First Posted Date  ICMJE April 12, 2010
Results First Submitted Date  ICMJE June 3, 2010
Results First Posted Date  ICMJE October 13, 2010
Last Update Posted Date November 1, 2015
Study Start Date  ICMJE October 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2010)
  • 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 ]
    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.
  • 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 ]
    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
  • 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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
  • 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 [ Time Frame: Day 5 & Day 7 ]
  • 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 [ Time Frame: Day 5 & Day 7 ]
  • 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 [ Time Frame: Day 5 & Day 7 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Single-center, Open-label, 2-way Crossover Relative Bioavailability and Safety Trial With Two Differing Strength Tablets (3 x 5 mg vs. 1 x 15 mg) of Sublingually Administered Org 5222 in Subjects With Schizophrenia or Schizoaffective Disorder.
Brief Summary A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective disorder delivered.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Asenapine 3x5mg followed by 1x15mg
    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
    Other Name: Org 5222, SCH 900274
  • Drug: Asenapine 1x15mg followed by 3x5mg
    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.
Study Arms  ICMJE
  • Experimental: Asenapine Sequence 1
    Intervention: Drug: Asenapine 3x5mg followed by 1x15mg
  • Experimental: Asenapine Sequence 2
    Intervention: Drug: Asenapine 1x15mg followed by 3x5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2010)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • must provide written informed consent after the scope and nature of the investigation has been explained to them, but before signing any trial-related activities, including screening evaluations;
  • must be at least 18 and less than 65 years of age;
  • can be either male or female; females must be either surgically sterile, postmenopausal for at least 1 year, or non-pregnant using a method of birth control that was acceptable to the investigator;
  • must be able to speak, read and understand English and be able to respond to questions and follow simple instructions;
  • must be diagnosed at the screening interview according to Diagnostic & Statistical Manual of Mental Disorders, 4th edition (DSM-IV), with non-first episode schizophrenia or schizoaffective disorder (295.70); if schizophrenia, must be of the following types: schizophrenia of the paranoid type (295.30), schizophrenia of the disorganized type (295.10), schizophrenia of the catatonic type (295.20), schizophrenia of the undifferentiated type (295.90), schizophrenia of the residual type (295.60);
  • must have discontinued all use of all antipsychotic medication except depot neuroleptics at least 3 days prior to baseline. For depot neuroleptics, subjects must have completed 1 dosing interval by the baseline interview;
  • must not have taken any experimental medication for at least 30 days prior to baseline;
  • with hypothyroidism, diabetes, high blood pressure, or chronic respiratory conditions can be considered as candidates for enrollment in the trial if their conditions are stable, they are receiving standard therapies for the condition, the prescribed dose and regimen of medication is stable for at least 3 months, and all appropriate clinical and laboratory parameters are within the clinically acceptable limits for the condition, and
  • must be willing to remain in the hospital a minimum of 14 days to approximately 17 days (minimum of a 3- to a maximum of a 7-day washout period, a minimum of an 8-day in-patient period, and a possible 3-day stabilization period, if needed, prior to discharge).

Exclusion Criteria:

  • they have any untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic, or cerebrovascular disease, or malignancy;
  • they are considered obese by the investigator (e.g., greater than 30% above ideal body weight);
  • they have a seizure disorder or are taking anticonvulsants to prevent seizures;
  • they have any clinically relevant electrocardiogram (ECG) abnormalities at the screening visit (Day -2) or at baseline (Day 0);
  • they have a history of a clinically significant cardiac event that required resuscitation;
  • at the screening visit, on admission to the trial, during the washout period or at baseline (Day 0), they have any clinically significant abnormal laboratory, vital sign, or physical examination findings which, in the opinion of the investigator, would preclude trial participation;
  • they require concomitant treatment with hypnotics (for sleep induction) other than chloral hydrate ≤3000 mg/day, or Ambien (zolpidem tartrate) ≤10 mg qhs, and (for agitation) a benzodiazepine such as lorazepam, ≤10 mg/day;
  • they have a score greater than mild at baseline (score >2) on any item of the Abnormal Involuntary Movement Scale (AIMS) assessment at screening and/or require ongoing treatment with anticholinergic medication beyond baseline (Day 0);
  • they have a history of significant drug and/or alcohol abuse (according to DSM-IV criteria 305.00) within 30 days before the screening visit;
  • they have a confirmed positive result on the alcohol/drug screen test for alcohol, illegal (excluding marijuana), or non-prescribed drugs at screening or at hospital admission;
  • they had a primary psychiatric diagnosis (according to DSM-IV criteria) other than schizophrenia or schizoaffective disorder;
  • they are actively suicidal at the screening visit, or become so at admission to the hospital, during the washout period, or at baseline (Day 0);
  • they have a Clinical Global Impression (CGI) (Severity of Illness) rating greater than moderately ill (score >4) at screening or baseline;
  • they are non-compliant (>25%) during the washout period (including baseline Day 0); or,
  • they are pregnant, intend to become pregnant during the course of the trial, or are currently nursing mothers during the course of the trial.
  • require concomitant medications that are substrates, inhibitors, or inducers of Cytochrome P450 CYP3A4.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01101464
Other Study ID Numbers  ICMJE P05937
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP