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

Sponsor
University of North Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT00004492
Collaborator
(none)
20
Enrollment
1
Location
23
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. 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.
Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 1999
Study Completion Date :
Sep 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina School of Medicine Chapel Hill North Carolina United States 27599-7070

    Sponsors and Collaborators

    • University of North Carolina

    Investigators

    • Study Chair: Eugene Paul Orringer, University of North Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004492
    Other Study ID Numbers:
    • 199/14273
    • UNCCH-FDR001531
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Jan 1, 2001
    Keywords provided by , ,
    genetic diseases and dysmorphic syndromes
    hematologic disorders
    rare disease
    sickle cell anemia
    Additional relevant MeSH terms:
    Anemia
    Anemia, Sickle Cell
    Clotrimazole
    Miconazole
    Hydroxyurea

    Study Results

    No Results Posted as of Mar 25, 2015