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

PHASE2TerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

March 26, 2018

Primary Completion Date

March 16, 2020

Study Completion Date

May 12, 2020

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

Trial Locations (11)

111539

"Moscow City State Healthcare Institution O.M. Filatov Municipal Clinical Hospital No. 15 of the Moscow Department of Healthcare", Moscow

119049

"State Budgetary Healthcare Institution of Moscow City Municipal Clinical Hospital No.1 named after N.I. Pirogov of Moscow Department of Healthcare", Moscow

119991

"Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)", Moscow

123182

"State Budgetary Healthcare Institution of Moscow City Municipal Clinical Hospital No.52 of Moscow Department of Healthcare", Moscow

150003

"State Autonomous Healthcare Institution of the Yaroslavl Region N.V. Solovyev Clinical Emergency Hospital", Yaroslavl

190068

"St. Petersburg State Budgetary Healthcare Institution Clinical Rheumatological Hospital No.25", Saint Petersburg

192242

"State Budget Institution Saint Petersburg Research Insitute of emergency care named after I.I. Dzhanelidze", Saint Petersburg

196143

"Limited Liability company Scientific Research Center Eco-safety", Saint Petersburg

300053

"State Insitution of healthcare Tula regional clinical dermatovenerologic dispensary", Tula

460000

"Federal State Budgetary Education Institution of Higher Education Orenburg State Medical University under Ministry of Healthcare of Russian Federation", Orenburg

603018

"State Budgetary Institution of Healthcare of Nizhny Novgorod region City Clinical hospital #13 of Avozavodskiy district", Nizhny Novgorod

All Listed Sponsors
collaborator

Covance

INDUSTRY

collaborator

Unimed Laboratories

INDUSTRY

collaborator

Data Matrix Solutions

OTHER

collaborator

Center of Pharmaceutical Analytics LLC

INDUSTRY

collaborator

OCT LLC

INDUSTRY

lead

R-Pharm

INDUSTRY