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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2001 by FDA Office of Orphan Products Development. Recruitment status was Recruiting

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	University of North Carolina
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004492

Purpose

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.

Condition	Intervention	Phase
Sickle Cell Anemia	Drug: clotrimazole Drug: hydroxyurea	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole Hydroxyurea

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	20
Study Start Date:	October 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004492

Locations

United States, North Carolina
University of North Carolina School of Medicine	Recruiting
Chapel Hill, North Carolina, United States, 27599-7070
Contact: Eugene Paul Orringer 919-843-9486

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of North Carolina

Investigators

Study Chair:

Eugene Paul Orringer

University of North Carolina

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004492 History of Changes
Other Study ID Numbers:	199/14273, UNCCH-FDR001531
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

genetic diseases and dysmorphic syndromes
hematologic disorders
rare disease
sickle cell anemia

Additional relevant MeSH terms:

Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Clotrimazole
Miconazole
Hydroxyurea
Anti-Infective Agents, Local

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Antineoplastic Agents
Antisickling Agents
Hematologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012