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Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sickle Cell Anemia

Intervention: clotrimazole (Drug); hydroxyurea (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of North Carolina

Official(s) and/or principal investigator(s):
Eugene Paul Orringer, Study Chair, Affiliation: University of North Carolina

Summary

OBJECTIVES: I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.

Clinical Details

Study design: Allocation: Randomized, Primary Purpose: Treatment

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months. Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks. Completion date provided represents the completion date of the grant per OOPD records

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

PROTOCOL ENTRY CRITERIA:

- -Disease Characteristics--

Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day

- -Prior/Concurrent Therapy--

Chemotherapy:

- No other concurrent antisickling agent

Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole

- -Patient Characteristics--

Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL Hepatic: AST/ALT no greater than 100 units/L Renal: Creatinine no greater than 1. 5 mg/dL Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior adverse reaction to hydroxyurea or clotrimazole

- No recent or progressive neurologic dysfunction

Locations and Contacts

University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7070, United States
Additional Information

Starting date: October 1999
Last updated: March 24, 2015

Page last updated: August 23, 2015

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