A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes - Tabular View

Tracking Information
First Received Date ^ICMJE	December 23, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	August 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00050843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
Official Title ^ICMJE
Brief Summary	The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myelodysplastic Syndromes
Intervention ^ICMJE	Drug: thalidomide
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	Completed
Enrollment ^ICMJE	220
Completion Date	February 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Eligible patients must have a diagnosis of myelodysplastic syndrome Life expectancy of at least 6 months. Patients must be able to adhere to the study visit schedule and other protocol requirements. Patients must understand and voluntarily sign an informed consent document. Women of childbearing potential (WCBP) must agree to practice abstinence or to use TWO methods of contraception beginning 4 weeks prior to the start of study medication and throughout the course of treatment. Males must use barrier contraception when engaging in reproductive sexual activity with women of childbearing potential.
Gender	Both
Ages	18 Years to 80 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	NCT00050843
Responsible Party
Study ID Numbers ^ICMJE	THAL-MDS-001
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Celgene Corporation
Verification Date	May 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP