GMI 1070: Reduction In Time To Resolution Of Vaso-Occlusive Crisis and Decreased Opioid Use In a Prospective, Randomized, Multi-Center Double Blind, Adaptive Phase 2 Study In Sickle Cell Disease
Telen M, Wun T, McCavit T, De Castro L, Krishnamurti L, Lanzkron S, Hsu L, Smith W, Rhee S, Magnani J, Thackray H. GMI 1070: Reduction In Time To Resolution Of Vaso-Occlusive Crisis and Decreased Opioid Use In a Prospective, Randomized, Multi-Center Double Blind, Adaptive Phase 2 Study In Sickle Cell Disease. Blood 2013, 122: 776. DOI: 10.1182/blood.v122.21.776.776.Peer-Reviewed Original ResearchVaso-occlusive crisisSickle cell diseaseOpioid useMedian timeTreatment groupsPlacebo groupCell diseaseSustained reductionVisual analog scale pain scoreTotal adverse event rateCumulative opioid useOral pain medicationPatients ages 12Opioid analgesic usePrimary efficacy endpointScale pain scoresPhase 2 studyPhase 3 studyPrimary efficacy analysisAdverse event ratesDaily opioid useStatistical significanceOral analgesiaSerious AEsVAS reduction