Clinical Trials Logo

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, 

See also
  Status Clinical Trial Phase
Completed NCT04134299 - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease N/A
Completed NCT04581356 - Voxelotor Sickle Cell Exercise Study Phase 4
Completed NCT02712346 - The Role of Endothelin-1 in Sickle Cell Disease Phase 1
Completed NCT01976416 - Novel Use Of Hydroxyurea in an African Region With Malaria Phase 3
Withdrawn NCT02162225 - Study of Beet Juice for Patients With Sickle Cell Anemia Phase 2
Completed NCT01137721 - State Of The Art Functional Imaging In Sickle Cell Disease
Withdrawn NCT00937144 - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil Phase 4
Terminated NCT01350232 - Treatment of Sickle Cell Anemia With Stem Cell Transplant N/A
Completed NCT00512564 - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00512226 - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00004143 - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes Phase 2
Completed NCT00004412 - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers Phase 2
Withdrawn NCT01925001 - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis Phase 2
Completed NCT01783990 - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed NCT01848691 - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis N/A
Completed NCT00874172 - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy N/A
Completed NCT01000155 - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease Phase 2
Completed NCT00236093 - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain Phase 2
Completed NCT00399074 - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia Phase 3
Completed NCT02065596 - Hematopoietic Stem Cell Transplant for Sickle Cell Disease Phase 1