6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543(25544)(COMPLETED)(P05777)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00265343

First received: December 12, 2005

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 12, 2005
Last Updated Date	March 18, 2013
Start Date ^ICMJE	December 2005
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 15, 2010)	Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ] [ Designated as safety issue: No ] Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].
Original Primary Outcome Measures ^ICMJE (submitted: December 12, 2005)	Long-term improvement in symptoms of schizophrenia (Information was omitted due to their commercial sensitivity, and will be revealed at a later date)
Change History	Complete list of historical versions of study NCT00265343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 15, 2010)	Change in Quality of Life Measured by Quality of Life Scale (QLS) [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ] [ Designated as safety issue: No ] Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].
Original Secondary Outcome Measures ^ICMJE (submitted: December 12, 2005)	Quality of life, depressive, anxiety and cognitive symptoms, patient questionnaires on treatment satisfaction and health status, and any adverse effects (Information was omitted due to their commercial sensitivity, and will be revealed at a later date)
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543(25544)(COMPLETED)(P05777)
Official Title ^ICMJE	A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)
Brief Summary	This is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: asenapine 5-10 mg sublingually twice daily for 26 weeks Drug: olanzapine 5-20 mg by mouth once daily for 26 weeks
Study Arm (s)	Experimental: 1 asenapine Intervention: Drug: asenapine Active Comparator: 2 olanzapine Intervention: Drug: olanzapine
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
Enrollment ^ICMJE	306
Completion Date	January 2008
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Continue to meet all demographic and procedural inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into this extension trial. Have demonstrated an acceptable degree of compliance and completed the 25543 trial, and would benefit from continued treatment according to the investigator. Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition. Have been judged to be medically noncompliant in the management of their disease.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00265343
Other Study ID Numbers ^ICMJE	25544, Aphrodite;, P05777
Has Data Monitoring Committee	Yes
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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