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NCT01846182: REGIONS
Research Examining Gulf War Illness in Our Nations Service Members
Phase 2 trial testing Duloxetine in Gulf War Illness in 112 participants. Terminated before completion.
1 August 2019
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 24 June 2015 |
| Primary completion | 1 August 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Duloxetine (duloxetine) — full drug profile →
- Pregabalin (Pregabalin) — full drug profile →
- Placebo
Conditions studied
- Gulf War Illness — all drugs for Gulf War Illness →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
Adults 44 to 70, any sex, with Gulf War Illness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Gulf War Illness: Mechanisms Underlying Brain Dysfunction and Promising Therapeutic Strategies.
Dickey B, Madhu LN, Shetty AK. · · 2021 · cited 54× · PMID 33164782 · DOI 10.1016/j.pharmthera.2020.107716
Verify or expand the search:
- PubMed search for NCT01846182
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Duloxetine
Trials testing the same drug.
- NCT07431606 — Duloxetine in Inflammatory Bowel Diseases · Phase 2 · not yet recruiting
- NCT07326163 — The Effect of Peppermint Oil Aromatherapy on Pain, Functional Capacity and Cost in Fibromyalgia Patients · NA · enrolling by invitation
- NCT06860984 — Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatograph · Phase 3 · recruiting
- NCT06807866 — Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT · Phase 4 · recruiting
- NCT06711978 — Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a R · NA · not yet recruiting
Other recruiting trials for Gulf War Illness
Currently open trials in the same condition.
- NCT05820893 — Resistant Potato Starch to Alleviate GWI · Phase 2 · recruiting
- NCT05367245 — Ca-Mg Butyrate in GWI · Phase 2 · recruiting
- NCT05972291 — Mechanisms of Gulf War Illness · NA · recruiting
- NCT05375812 — NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH) · recruiting
- NCT05675878 — Confirmation of Diet as a Treatment for Gulf War Illness · Phase 3 · recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01846182 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 12 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01846182.
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