A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia - Tabular View

Tracking Information
First Received Date ^ICMJE	August 16, 2002
Last Updated Date	January 6, 2009
Start Date ^ICMJE	July 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Official Title ^ICMJE	A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
Brief Summary	The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: SM-13496
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	330
Completion Date	October 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria: The patient has a primary diagnosis of schizophrenia The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening The patient has had a duration of illness of at least one year. The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS The patient is able to remain off antipsychotic medication for a 4 day washout period Exclusion criteria: The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening. The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline Pregnancy
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00044044
Responsible Party
Study ID Numbers ^ICMJE	D1050049
Study Sponsor ^ICMJE	Sumitomo Pharmaceuticals America
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sumitomo Pharmaceuticals America
Verification Date	May 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP