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Study of GMI-1070 for the Treatment of Sickle Cell Pain Crisis

NCT01119833 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-05-13

No results posted yet for this study

Summary

GMI-1070 is a new drug that may reduce the stickiness of cells in the blood. The purpose of this study is to evaluate whether GMI-1070 can reduce the time it takes for pain to go away in patients with vaso-occlusive crisis (also known as a sickle cell pain crisis). The study will also collect information on the safety of GMI-1070, how much of the drug is in the blood and urine, and if there are any other effects when used in patients who are in the hospital for a sickle cell pain crisis.

Conditions

Interventions

DRUG

GMI-1070

Intravenous GMI-1070 given twice a day during hospital stay for sickle cell pain crisis

DRUG

Placebo

Intravenous Placebo given twice a day during hospital stay for sickle cell pain crisis

Sponsors & Collaborators

  • GlycoMimetics Incorporated

    lead INDUSTRY

Principal Investigators

  • Marilyn J Telen, MD · Duke University

  • Helen Thackray, MD · GlycoMimetics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01119833 on ClinicalTrials.gov