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ACTH vs Betamethasone in Hospitalized Patients With Acute Gout
Plain-language guide to NCT04306653: not phased randomized trial of ACTH (Corticotropin), gout, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04306653
- Phase
- not phased
- Status
- status unknown
- Start
- 2018-01-05
- Completion (planned or actual)
- 2020-04
- Participants
- 60 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Gout Attack
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested ACTH (Corticotropin) for gout.
It had two arms (groups): ACTH (experimental) and Betamethasone (active comparator).
Patients with acute gout treated with ACTH.
Patients with acute gout treated with betamethasone.
The registry classes the interventions as drug.
More on the Plan
BACKGROUND Treatment of gout can be either simple and straightforward in many cases, or extremely problematic in others.
Current guidelines recommend the use of non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine as first-line treatment.
However, patients with gout typically have multiple comorbidities that often preclude the use of these drugs.
The management of gout can be even more troublesome in the hospital setting.
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: Able to provide written informed consent. Diagnosis of acute gout according to ACR/EULAR classification criteria -.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: unable to provide written informed consent -.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.
Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2018-01-05 with completion listed for 2020-04.
It ran at 1 site in Greece.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Pain VAS (time frame: 12 hours). Pain VAS (time frame: 24 hours). Pain VAS (time frame: 48 hours).
It also tracked 20 secondary outcomes, for example Physician global assessment, Physician global assessment, Physician global assessment, Physician global assessment, Patient global assessment and Patient global assessment.
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.