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Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia

NCT01960413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-03-26

Study results available
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Summary

In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.

Conditions

  • Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)

Interventions

DRUG

Montelukast added to Hydroxyurea

DRUG

Placebo added to Hydroxyurea

Sponsors & Collaborators

  • Medical College of Wisconsin

    collaborator OTHER

  • Versiti

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Michael R. DeBaun, MD, MPH · Vanderbilt University Medical Center

  • Joshua Field, MD, MS · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960413 on ClinicalTrials.gov