SchizophreniaPhase 2NCT01101464

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)

A Phase 2 study testing Asenapine 3x5mg followed by 1x15mg and Asenapine 1x15mg followed by 3x5mg in people with Schizophrenia and Schizoaffective Disorder, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Asenapine 3x5mg followed by 1x15mg and Asenapine 1x15mg followed by 3x5mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: No sites listed yet
Study dates: Oct 2002to Dec 2002
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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).

Who cannot join

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;

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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.

About this study

Official title: 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.

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.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Asenapine 3x5mg followed by 1x15mg, Asenapine 1x15mg followed by 3x5mg
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Asenapine 3x5mg followed by 1x15mgDrug
Also called Org 5222, SCH 900274
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 1x15mg followed by 3x5mgDrug
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 groups in NCT01101464
Study group	Role	What they receive
Asenapine Sequence 1	Experimental	Not described Receives: Drug: Asenapine 3x5mg followed by 1x15mg
Asenapine Sequence 2	Experimental	Not described Receives: Drug: Asenapine 1x15mg followed by 3x5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
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.
Measured: Day 5 & Day 7
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)
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
Measured: Day 5 & Day 7
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)
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.
Measured: Day 5 & Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Dec 2002

First posted12 Apr 2010 (estimated)
Study startOct 2002
Primary completionDec 2002
Study completionDec 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101464
Sponsor's protocol ID: P05937
Status last verified: Feb 2022
First submitted: 3 Mar 2010
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT01101464
Acronym / sponsor ID: P05937
Conditions: Schizophrenia, Schizoaffective Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Dec 2002 (actual)
Study completion: Dec 2002 (actual)
First posted: 12 Apr 2010 (estimated)
Results: Posted 13 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Asenapine Sequence 1	Experimental	Drug: Asenapine 3x5mg followed by 1x15mg
Asenapine Sequence 2	Experimental	Drug: Asenapine 1x15mg followed by 3x5mg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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);

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Asenapine 3x5mg followed by 1x15mgAlso: Org 5222, SCH 900274Three 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	Drug	Asenapine Sequence 1
Asenapine 1x15mg followed by 3x5mgOne 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.	Drug	Asenapine Sequence 2

Primary outcome

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.

Results and safety

Results posted to the registry on 13 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Asenapine, (3) 5mg Then (1) 15 mg	4	4
Asenapine, (1) 15 mg Then (3) 5 mg	4	4

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Asenapine 3x5mg n = 8	Asenapine 1x15mg n = 8
Value	6.89 (3.08)	6.38 (2.76)

Population analysed: All participants were included in both treatment comparisons (as per cross over design).

Primary outcome: 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. Mean (Full Range). Unit: Hours

Measure	Asenapine 3x5mg n = 8	Asenapine 1x15mg n = 8
Value	1.25 (0.5 to 2.0)	1.00 (0.5 to 3.0)

Population analysed: All participants were included in both treatment comparisons (as per cross over design).

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Asenapine 3x5mg n = 8	Asenapine 1x15mg n = 8
Value	41.3 (18.2)	41.1 (17.1)

Population analysed: All participants were included in both treatment comparisons (as per cross over design).

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asenapine, (3) 5 mg Then (1) 15 mg	0 of 4 (0%)	2 of 4 (50%)	Not reported
Asenapine, (1) 15 mg Then (3) 5 mg	0 of 4 (0%)	3 of 4 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Asenapine 3x5mg followed by 1x15mg and Asenapine 1x15mg followed by 3x5mg in people with Schizophrenia and Schizoaffective Disorder, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.