drugset / Trial / NCT01846182

Research Examining Gulf War Illness in Our Nations Service Members

NCT01846182

RandomizedParallel-groupQuadruple-blindTreatment

Summary

At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from Gulf War Illness (GWI). Despite considerable research, effective treatments remain elusive. GWI refers to a complex of symptoms that typically include widespread chronic pain, persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep disturbances and unexplained fatigue. These symptoms are similar to that of fibromyalgia syndrome (FMS), another multi-symptom condition. Whereas, effective treatments for GWI have yet to be found, the FDA has approved duloxetine and pregabalin for the treatment of FMS. The lack of progress in finding effective treatments for GWI, and the similarities between GWI and FMS, provides a rationale for determining if these medications can provide relief to Veterans who suffer from GWI. This randomized controlled trial will test the efficacy of Duloxetine and Pregabalin for treating Gulf War Veterans who suffer from GWI.

Timeline

Start
2015-06-24
Primary completion
2019-08-01
Completion
2019-08-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Duloxetine Small molecule 60 mg
Comparator Pregabalin Small molecule 300 mg

Indications