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Treatment of Refractory Gout With ACTH or Methylprednisolone

Plain-language guide to NCT04808856: not phased randomized trial of ACTH (Corticotropin), gout, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04808856
Phase
not phased
Status
status unknown
Start
2021-04-01
Completion (planned or actual)
2022-04-01
Participants
60 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Gout
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested ACTH (Corticotropin) for gout.

To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.

It had two arms (groups): ACTH (experimental) and Methylprednisolone (active comparator).

Adrenocorticotropic Hormone.

Methylprednisolone.

The registry classes the interventions as drug.

More on the Plan

When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated .

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: (123 items and 1 item from 4-7 are met simultaneously) :. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout. Acute gouty arthritis. Repeated attacks and prolonged pain (more than 1 month);. Poor response or intolerance to colchicine or NSAIDs;.

The full record lists 8 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got ACTH (Corticotropin) and who got the comparison, which limits bias.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label ACTH (Corticotropin) study: the gout participants and staff both knew the treatment.

It started in 2021-04-01 with completion listed for 2022-04-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Measurement of pain (time frame: 7 days). Arthritis score (time frame: 7 days).

It also tracked 1 secondary outcome, for example Recurrence rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of ACTH (Corticotropin) in 60 people with gout.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Gout research.

Our Notes on the Compound

ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.