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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

clotrimazole

hydroxyurea

About this trial

This is an interventional treatment trial for Sickle Cell Anemia focused on measuring genetic diseases and dysmorphic syndromes, hematologic disorders, rare disease, sickle cell anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004492

First Posted

October 18, 1999

Last Updated

March 24, 2015

Sponsor

University of North Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00004492

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2001

Overall Recruitment Status

Completed

Study Start Date

October 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of North Carolina

4. Oversight

5. Study Description

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.

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. Completion date provided represents the completion date of the grant per OOPD records

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Anemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

clotrimazole

Intervention Type

Drug

Intervention Name(s)

hydroxyurea

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugene Paul Orringer

Organizational Affiliation

University of North Carolina

Official's Role

Study Chair

Facility Information:

Facility Name

University of North Carolina School of Medicine

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7070

Country

United States

Sickle Cell Anemia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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