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Gulf War Illness Inflammation Reduction Trial

NCT02506192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-12-10

Study results available
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Summary

The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes measures include changes from baseline levels of GWI-associated biomarkers of inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and HRQOL with respect to mental functioning.

Conditions

Interventions

DRUG

Modified-Release Prednisone

Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks

DRUG

Placebo

Placebo oral tablets (2x5mg) daily for 8 weeks

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Minneapolis Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Ronald R Bach, PhD · Minneapolis Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2023-10-19
Completion
2023-10-19

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02506192 on ClinicalTrials.gov