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

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ClinicalTrials.gov Identifier: NCT00004492
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

October 18, 1999
October 19, 1999
March 25, 2015
October 1999
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Complete list of historical versions of study NCT00004492 on ClinicalTrials.gov Archive Site
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Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
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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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Sickle Cell Anemia
  • Drug: clotrimazole
  • Drug: hydroxyurea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
September 2001
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004492
199/14273
UNCCH-FDR001531
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University of North Carolina
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Study Chair: Eugene Paul Orringer University of North Carolina
FDA Office of Orphan Products Development
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP