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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004492
Other study ID # 199/14273
Secondary ID UNCCH-FDR001531
Status Completed
Phase Phase 1/Phase 2
First received October 18, 1999
Last updated March 24, 2015
Start date October 1999
Est. completion date September 2001

Study information

Verified date January 2001
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
clotrimazole

hydroxyurea


Locations

Country Name City State
United States University of North Carolina School of Medicine Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina

Country where clinical trial is conducted

United States, 

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