NCT04012294

Effects of Allopurinol on Inflammation and Ultrasonographic Changes in People With Elevated Uric Acid But no Symptoms

Status unknown Phase 3 Last updated 23 January 2020

What this trial tests

Phase 3 trial testing Allopurinol Pill in Musculoskeletal Degeneration in 200 participants. Status unknown.

Timeline

30 August 2019

Primary endpoint
30 July 2020

28 February 2021

Quick facts

Lead sponsor	Instituto Nacional de Cardiologia Ignacio Chavez
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	30 August 2019
Primary completion	30 July 2020
Estimated completion	28 February 2021
Sites	2 locations across Mexico

Drugs / interventions tested

• Allopurinol Pill — full drug profile →

Conditions studied

• Musculoskeletal Degeneration — all drugs for Musculoskeletal Degeneration →
• Inflammation — all drugs for Inflammation →
• Hyperuricemia — all drugs for Hyperuricemia →

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez — full company profile →

Who can join

18 and older, any sex, with Musculoskeletal Degeneration or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hyperuricemia is a metabolic alteration defined as the presence of serum urate levels higher than 7 mg/dL. This has proven to be the maximum limit of solubility of urate in serum, any higher concentration leads to precipitation and eventually to the formation of monosodium urate (MSU) crystals. The accumulation of said crystals can manifest as gouty arthritis, uric acid nephropathy, urolithiasis or chronic tophaceous gout.

A strong relation between hyperuricemia and other chronic degenerative diseases, including diabetes mellitus, systemic arterial hypertension, obesity and metabolic syndrome, has been consistently proven.

Hypouricemic pharmacological agents have shown a decrease in cardiovascular complications and death in patients with gout.

A series of studies conducted on individuals with asymptomatic hyperuricemia using musculoskeletal ultrasound (MSUS) have shown the presence of morphostructural changes suggestive of MSU crystal deposits, combined with an elevation in a series of inflammation markers to a degree similar to those found in patients with chronic gout.

Even though, there is evidence of morphostructural damage in individuals with asymptomatic hyperuricemia, there are no clinical, laboratorial or imaging parameters that indicate when hypouricemic treatment should be started.

This clinical trial is proposed as a proof of concept which is looking to evaluate if treatment with allopurinol induces changes in levels of inflammatory markers in individuals with asymptomatic hyperuricemia and morphostructural changes suggestive of MSU crystal deposits. this proof of concept is not looking to measure the efficiency, effectiveness or security of the treatment.

Our Hypothesis is that Individuals with asymptomatic hyperuricemia and morphostructural changes evidenced by MSUS (double contour sing, tophi, aggregates) will show a decent in inflammatory markers and their morphostructural changes will diminish or revert after treatment with allopurinol.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Senescent CD4⁺CD28^null cells are increased in chronic hyperuricemia, show aberrant effector phenotypes, and are reversed after allopurinol therapy: a proof-of-concept pilot study.
   Amezcua-Guerra LM, Espinosa-Bautista F, Hopf-Estandía K, Valdivieso-Ruiz M, et al · · 2023 · cited 4× · PMID 37072512 · DOI 10.1007/s10067-023-06595-8