Research Examining Gulf War Illness in Our Nations Service Members (NCT01846182) | Clinical Trial Compass
TerminatedPhase 2
Research Examining Gulf War Illness in Our Nations Service Members
Stopped: Terminated by Funder
United States112 participantsStarted 2015-06-24
Plain-language 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.
Who can participate
Age range44 Years – 70 Years
SexALL
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Inclusion Criteria:
* Living in Central Texas near Killeen, Austin, Temple or Waco
* Served on active military duty and deployed to the Persian Gulf region for some period between August 1990 \& July 1991
* English speaking and able to understand the consent form and study questionnaires
* Willing to be randomized to treatment and participate in 1-month follow up
* men \& women between the ages of 43 to 70
* meet Kansas GWI case definition for the diagnosis of GWI
* report a baseline score \> 4 on a 10-point Pain Visual Analog Scale (VAS)
* female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control (for example, oral contraceptives or Norplant; a reliable barrier method of birth control \[diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam); intrauterine devices; partner with vasectomy; or abstinence) during the study and for 2 months following the last dose of the study drug. \[Note that this inclusion criterion applies only to females of childbearing potential. Females of childbearing potential are defined as women not surgically sterilized and between menarche and 2 years post-menopause.\]
Exclusion Criteria:
* Unstable or poorly controlled chronic medical illness such as Diabetes type-II, Hypertension (HTN), heart disease, endocrine disorders, narrow angle glaucoma
* Significant Centra…