Chemotherapy Induced Anemia Clinical Trial
Official title:
A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Verified date | January 2009 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy
Status | Completed |
Enrollment | 122 |
Est. completion date | August 2005 |
Est. primary completion date | March 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 79 Years |
Eligibility |
Inclusion Criteria: - Cancer patients Exclusion Criteria: - a history of myocardial, cerebral or pulmonary infarction - severe hypertension beyond control by drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The increase in Hb concentration | week 8 | No | |
Secondary | Changes in QOL scores | 8 weeks | No |
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