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Sponsors and Collaborators: |
University of Louisville Ortho Biotech, Inc. |
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Information provided by: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00624312 |
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.
Condition | Intervention | Phase |
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Cancer |
Drug: Procrit Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations |
Estimated Enrollment: | 86 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Pre-operatively randomized to Procrit
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Drug: Procrit
10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit |
2: Placebo Comparator
Pre-operatively randomized to placebo
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Drug: Placebo
10 days prior to surgery - injection with 60,000 IU of placebo Day of surgery - injection with 60,000 IU of placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Undergoing a major surgical oncology procedure as defined below:
Exclusion Criteria:
Contact: Susan Ellis, CCRP | 502-629-3384 | susan.ellis@louisville.edu |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Principal Investigator: Robert Martin, MD |
Principal Investigator: | Robert Martin, MD | University of Louisville |
Responsible Party: | University of Louisville ( Robert Martin, MD ) |
Study ID Numbers: | 07.0048 |
Study First Received: | February 15, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00624312 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Procrit Erythropoietin Patients undergoing major surgical oncology operations |
Epoetin Alfa Hematinics |
Epoetin Alfa Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |