Trial record 13 of 65 for:
sickle cell anemia OR sickle cell disease OR hemoglobin S disease OR hemoglobin SS disease | Open Studies | NIH, U.S. Fed
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by FDA Office of Orphan Products Development.
Recruitment status was Recruiting
University of North Carolina
Information provided by:
FDA Office of Orphan Products Development
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2001
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.
Sickle Cell Anemia
Primary Purpose: Treatment
| Estimated Enrollment:
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
PROTOCOL ENTRY CRITERIA:
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
- No other concurrent antisickling agent
Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole
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
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior adverse reaction to hydroxyurea or clotrimazole
- No recent or progressive neurologic dysfunction
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004492
|University of North Carolina School of Medicine
|Chapel Hill, North Carolina, United States, 27599-7070 |
|Contact: Eugene Paul Orringer 919-843-9486 |
University of North Carolina
||Eugene Paul Orringer
||University of North Carolina
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 18, 1999
||June 23, 2005
||United States: Federal Government
Keywords provided by FDA Office of Orphan Products Development:
genetic diseases and dysmorphic syndromes
sickle cell anemia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors