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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack

NCT04067492 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-07-25

Study results available
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Summary

The primary goal of the study was to evaluate the parameters of efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of RPH-104 in adult patients with acute gout attack.

Conditions

  • Gout Attack

Interventions

DRUG

RPH - 104

solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

DRUG

Voltaren®

Enteric-coated tablets, 25 mg and 50 mg

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Unimed Laboratories

    collaborator INDUSTRY

  • Data Matrix Solutions

    collaborator OTHER

  • Center of Pharmaceutical Analytics LLC

    collaborator INDUSTRY

  • OCT LLC

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2020-03-16
Completion
2020-05-12

Countries

  • Russia

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 NCT04067492 on ClinicalTrials.gov