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ACTH vs Betamethasone in Hospitalized Patients With Acute Gout

NCT04306653 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-13

No results posted yet for this study

Summary

Background: Hospitalized patients usually have significant comorbidities and receive multiple medications which leads to a high frequency of contraindications to standard treatment options for acute gout (NSAIDs, colchicine, steroids). Adrenocorticotropic hormone (ACTH) has long been used in acute gout, exhibiting significant clinical efficacy and an excellent safety profile. Aim: To assess 1) the clinical efficacy of ACTH in gout compared to betamethasone in hospitalized patients 2) the safety profile of ACTH vs betamethasone and 3) the effect of ACTH on immune responses and metabolic parameters. Methods: This is a randomized, open label comparative study directly comparing ACTH vs betamethasone for acute gout. The investigators plan to recruit 60 hospitalized patients who will be randomly assigned to either the ACTH or the betamethasone group on a 1:1 basis. Participants will be clinically assessed at baseline and at 24, 48, 72h and 5 days time points. (Intensity of pain, physician and patient global assessment, tenderness, swelling and redness). Serum and plasma samples will be collected at baseline and at the 24, 48, 72h time points from all study paticipants. The investigators will assess the effect of ACTH vs betamethasone on several metabolic parameters concentrating on glucose homeostasis. Results: The study is currently recruiting patients. Conclusions: If the efficacy and safety profile of ACTH is verified in this randomized controlled trial, the use of ACTH for the treatment of gout in the hospital setting will be strongly supported.

Conditions

  • Gout Attack

Interventions

DRUG

ACTH

patients with acute gout will receive 100 IU ACTH IM

DRUG

Betamethasone

patients with acute gout will receive 6 mg of betamethasone

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • Dimitrios Daoussis · University of Patras Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2020-04-30
Completion
2020-05-31

Countries

  • Greece

Study Locations

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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 NCT04306653 on ClinicalTrials.gov