Why the study?
Does GMI-1070 reduce the time to resolution of vaso-occlusive events and opioid use in patients with sickle cell disease?
Population
76 patients with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC)
Comparison
GMI-1070 given every 12 hours for up to 15… vs Placebo given every 12 hours for up to 15 doses…
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
up to 15 doses (every 12 hours)
Authors
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Primary endpoint missed for vaso-occlusive resolution; leaves open opioid-sparing potential in sickle cell disease pending larger trials.
Does GMI-1070 reduce the time to resolution of vaso-occlusive events and opioid use in patients with sickle cell disease?
In a phase 2 study of patients with sickle cell disease, GMI-1070 did not significantly reduce the time to resolution of vaso-occlusive crises but did significantly decrease cumulative IV opioid use.
Telen et al. (2015) studied this question.
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