MedTrace Logo

Research Examining Gulf War Illness in Our Nations Service Members

NCT01846182 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-03-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Gulf War Illness

Interventions

DRUG

Duloxetine

serotonin norepinephrine reuptake inhibitor

DRUG

Pregabalin

alpha-2-alpha subunit calcium channel ligand

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Charles J Foulks, M.D. · Central Texas Veterans Health Care System, Temple, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
44 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-24
Primary Completion
2019-08-01
Completion
2019-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01846182 on ClinicalTrials.gov