Completed

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

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What is being tested

clotrimazole

+ hydroxyurea

Drug
Who is being recruted

Anemia+10

+ Anemia, Hemolytic

+ Anemia, Hemolytic, Congenital

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorUniversity of North Carolina
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

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

NCT00004492
Principal SponsorUniversity of North Carolina
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, HemolyticAnemia, Hemolytic, CongenitalHemic and Lymphatic DiseasesHemoglobinopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesAnemia, Sickle CellHematologic DiseasesGenetic Diseases, InbornRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of North Carolina School of Medicine

Chapel Hill, United StatesOpen University of North Carolina School of Medicine in Google Maps
CompletedOne Study Center