NCT00004492

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2001

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Sickle Cell Anemia

Keywords

genetic diseases and dysmorphic syndromeshematologic disordersrare diseasesickle cell anemia

Interventions

clotrimazoleDRUG
hydroxyureaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7070, United States

Location

MeSH Terms

Conditions

Anemia, Sickle CellGenetic Diseases, InbornHematologic DiseasesRare Diseases

Interventions

ClotrimazoleHydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemic and Lymphatic DiseasesHemoglobinopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesOrganic Chemicals

Study Officials

  • Eugene Paul Orringer

    University of North Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

October 1, 1999

Study Completion

September 1, 2001

Last Updated

March 25, 2015

Record last verified: 2001-01

Locations

US(1)