CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Modified-Release Prednisone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02506192
NCT02506192Phase 2Completed
CompareCT.gov

Gulf War Illness Inflammation Reduction Trial

Minneapolis Veterans Affairs Medical Center·interventional·Posted Jul 23, 2015·Updated Dec 10, 2024

In Brief

A Phase 2 clinical trial evaluating Modified-Release Prednisone and Placebo for Chronic Inflammation and 3 related conditions. Completed, enrolled 83 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Inflammation, Chronic Pain, Fatigue, Cognitive Impairment
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartJul 1, 2015
Primary CompletionOct 19, 2023
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 10.9 years ago

Interventions

Modified-Release Prednisonedrug

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

Placebodrug

Placebo oral tablets (2x5mg) daily for 8 weeks