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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04808856
Other study ID # ACTH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date April 1, 2022

Study information

Verified date March 2021
Source Shanghai 10th People's Hospital
Contact Hang Sun, MD
Phone 86-21-66301004
Email sunhang1027@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - (123 items and 1 item from 4-7 are met simultaneously) : 1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout 2. Acute gouty arthritis 3. Age =18 4. Repeated attacks and prolonged pain (more than 1 month); 5. poor response or intolerance to colchicine or NSAIDs; 6. Liver and kidney dysfunction; 7. Old age; Exclusion Criteria: - 1) History of gastrointestinal bleeding and active ulcer 2) The application history of glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4) Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6) Mental illness inability to communicate or have language barriers and inability to fully understand and cooperate 7) negligent compensatory heart failure, unstable angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe arrhythmia occurred within 6 months 8) The investigator did not consider it appropriate to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Adrenocorticotropic Hormone
Adrenocorticotropic Hormone Injection 25u qd iv *3d
Methylprednisolone Injection
Methylprednisolone Injection 40mg qd iv *3d

Locations

Country Name City State
China Shanghai Tenth People's hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of pain Visual analogue scale (VAS 0-10) 7 days
Primary Arthritis score Arthritis (redness and swelling fever 0-3) score 7 days
Secondary Recurrence rate Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence) 1 month
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