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

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ClinicalTrials.gov Identifier: NCT04067492
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
Covance
ZAO Unimed Laboratories
Data Matrix Solutions
Information provided by (Responsible Party):
R-Pharm

Brief Summary:
The primary goal of the study is 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.

Condition or disease Intervention/treatment Phase
Gout Attack Drug: RPH - 104 Drug: Voltaren® Phase 2

Detailed Description:

The study will consist of two periods:

Period 1. During Period 1 of the study, the patients who meet the eligibility criteria are enrolled to cohorts consisting of 22 patients and randomized to receive either RPH-104 4 mg or Voltaren® (diclofenac) in the 15:7 ratio (15 RPH-104: 7 Voltaren® (diclofenac)). In order to prevent damage to the gastric or duodenal mucosa, the patients receiving Voltaren® (diclofenac) will also be given Ortanol® (omeprazole) as a concomitant therapy agent.

Period 2. Period 2 begins after 22 patients in period 1 have been enrolled. During Period 2, the enrolled patients are randomly distributed to one of five treatment groups: four groups to receive RPH-104 in different doses :20 mg, 40 mg, 80 mg and 160 mg and one active control group to receive Voltaren® (diclofenac). During Period 2, it is planned to enroll 14 patients into each of the RPH-104 -treatment groups and 7 patients into the Voltaren® (diclofenac) group.

Subject enrolment during Periods 1 and 2 is successive. No intervals between enrolment of subjects in the dose cohorts are envisaged. Thus, the subjects in Period 2 will start to be enrolled immediately after the end of enrolment of the subjects in Period 1.

Total number of patients which are planned to be enrolled for the study: 85 (15 patients in the group of treatment with RPH-104 4 mg and 14 patients in the each of the other treatment groups)

For patients who cannot endure pain, a rescue therapy agent (Triamcinolone 40 mg) is administered intramuscularly 2 hours after the first dose of the test drug in order to enhance the treatment. If the disease attack relapses after using the rescue therapy, treatment of acute gout attack shall be conducted in accordance with routine practice adopted at the healthcare institution.

The primary efficacy endpoints are evaluated 72 hours after the end of administration of the test drug. The secondary efficacy endpoints are evaluated for 45 days of the treatment period and follow-up. The safety parameters are evaluated for 60 days of the treatment period and follow-up. Total duration of the study for a volunteer is not more than 70 days.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose, Active-controlled Randomized Phase IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 (RPH-104/L04018) Administered at Different Doses to Patients With Acute Gout Attack
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: RPH - 4 mg
Subjects randomized to receive RPH-104, 4 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 4 mg, 0.1 mL of RPH-104 solution is injected.
Drug: RPH - 104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

Experimental: RPH - 20 mg
Subjects randomized to receive RPH-104, 20 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 20 mg, 0.5 mL of RPH-104 solution is injected.
Drug: RPH - 104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

Experimental: RPH - 40 mg
Subjects randomized to receive RPH-104, 40 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 40 mg, 1 mL of RPH-104 solution is injected.
Drug: RPH - 104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

Experimental: RPH - 80 mg
Subjects randomized to receive RPH-104, 80 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 80 mg, 2 mL (whole vial) of RPH-104 solution is injected.
Drug: RPH - 104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

Experimental: RPH - 160 mg
Subjects randomized to receive RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites. (1 vial of 2mL solution per each site)
Drug: RPH - 104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

Active Comparator: Voltaren® (diclofenac)
Subjects randomized to receive Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose)
Drug: Voltaren®
Enteric-coated tablets, 25 mg and 50 mg
Other Name: Diclofenac




Primary Outcome Measures :
  1. Change in pain intensity in the assessed joint 72 hours after the initiation of treatment in comparison to baseline [ Time Frame: Baseline and 72 hours after the initiation of treatment with the test drug ]
    Change in pain intensity in the assessed joint 72 hours after the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) in comparison to baseline. VAS is a hard copy 100 mm scale with the indications:"Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)) The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".


Secondary Outcome Measures :
  1. Change in pain intensity in the assessed joint in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment and compared to baseline [ Time Frame: Baseline and 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment ]
    Change in pain intensity in the assessed joint in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) and compared to baseline

  2. Proportion of patients who assessed the response to therapy with the test drug as "Excellent" or "Good" [ Time Frame: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment with the test drug ]
    Proportion of patients who assessed the response to therapy with the test drug as "Excellent" or "Good" in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug

  3. Change in the rate of swelling and erythema of the assessed joint evaluated after the initiation of treatment with the test drug [ Time Frame: Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug ]
    Change in the rate of swelling and erythema of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. For the assessment, the categorical scales consistent with the Form for evaluation (Investigator's Assessment) of the rate of edema, tenderness, erythema, restriction of movements will be used. The rates of swelling are specified in the evaluation form as "no", "mild", "moderate" and "severe"; the rates of "erythema" are specified as "no", "yes", "impossible to evaluate".

  4. Change in the rate of movement restrictions in the specified timeframes after initiation of treatment [ Time Frame: Baseline and in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug ]
    Change in the rate of movement restrictions in the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. For the assessment, the categorical scales consistent with the Form for evaluation (Investigator's Assessment) of the rate of edema, tenderness, erythema, restriction of movements will be used. The rates of movement restrictions (amplitide of movements) are specified in the evaluation form as "Normal amplitude", " slightly restricted amplitude", " moderately restricted amplitude" ,"severely restricted amplitude" and "movements in the joints are impossible ".

  5. Time to achieve the 50% decrease in pain intensity in the assessed joint relative to the baseline [ Time Frame: Baseline and one of the pain intensity measurements in accordance with the schedule: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment ]
    Time to achieve the 50% decrease in pain intensity in the assessed joint relative to the baseline VAS level

  6. Proportion of patients who received a rescue therapy agent [ Time Frame: 72 hours prior to the initiation of treatment with the test drug and during the entire course of treatment ]
    Proportion of patients who received a rescue therapy agent within 72 hours prior to the initiation of treatment with the test drug and during the entire course of treatment

  7. Changes in the Health Assessment Questionnaire (HAQ) parameters within the specified timeframes after the start of the treatment with the test drug [ Time Frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug ]
    Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. HAQ is a hard copy Questionnaire to be completed by patient in order to discover how partient's illness affects his/her ability to function in daily life. The better outcome would be "Without any difficulty", the worse outcome would be "Unable to do".


Other Outcome Measures:
  1. Pharmacokinetics (PK) - area under the plasma concentration-of RPH-104 under the subcutaneous administration [ Time Frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) ]
    Including area under the plasma concentration-time curve over the dosing interval (AUC0-tau)

  2. Pharmacokinetics (PK) - Area under the active substance concentration- of RPH-104 under the subcutaneous administration [ Time Frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) ]
    Including Area under the active substance concentration-time curve from zero (before drug administration) to infinity (AUC0-∞)

  3. Pharmacokinetics (PK) - Maximum concentration of the active substance -of RPH-104 under the subcutaneous administration [ Time Frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) ]
    Including Maximum concentration of the active substance (Cmax)

  4. Pharmacokinetics (PK) of RPH-104 under the subcutaneous administration [ Time Frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) ]
    Including elimination constant (Kel)

  5. Pharmacokinetics (PK) -Time to reach maximum concentration of the active substance - of RPH-104 under the subcutaneous administration [ Time Frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) ]
    Including Time to reach maximum concentration of the active substance (tmax)

  6. Pharmacokinetics (PK) - terminal half-life -of RPH-104 under the subcutaneous administration [ Time Frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) ]
    Including terminal half-life (T 1/2)

  7. Change in the serum rate of high-sensitive CRP (hs-CRP) in specified timeframes [ Time Frame: Baseline and in 24, 72 hours, on Days 5, 6, 15, 29 and 45 after the initiation of treatment with the test drug ]
    Change in the serum rate of high-sensitive CRP (hs-CRP) in 24, 72 hours, on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug compared to baseline

  8. Change in the rate of serum amyloid protein A in the specified timeframes [ Time Frame: Baseline and in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug ]
    Change in the rate of serum amyloid protein A in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline

  9. Change in the serum rates of cytokines (IL-1α, IL-1β, Interleukin -1 Receptor Antagonist (IL-1RA), IL-6, IL-8, Tumor Necrosis Factor (TNF-α)) [ Time Frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug ]
    Change in the serum rates of cytokines (IL-1α, IL-1β, IL-1RA, IL-6, IL-8, TNF-α) in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline

  10. Immunogenicity evaluation of blood samples [ Time Frame: before administration of RPH-104, on Day 15 and Day 45 ]
    Concentrations of anti-RPH-104 antibodies, including neutralizing antibodies, will be assessed before administration of RPH-104, on Day 15 and Day 45



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. The subject has given his / her informed consent to participate in this study; the Informed Consent Form has been signed both by the patient and the Investigator;
  • 2. Established diagnosis of gout according to Gout Classification Criteria established by the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) in 2015;
  • 3. Pain in at least one joint at the screening and immediately prior to initiation of therapy with the study drugs, with intensity 50 mm to 100 mm according to the Visual Analogue Scale (VAS);
  • 4. Development of acute gout attack within 120 hours (5 days) prior to the randomization date;
  • 5. History of 1 or more acute gout attacks prior to the Screening Visit;
  • 6.The patients receiving uric acid-lowering drugs should continue receiving these drugs at a constant dose for at least 4 weeks prior to enrolment to the study and throughout the entire study period; the patients not receiving uric acid-lowering drugs may start receiving this treatment after the end of the study;
  • 7. Body mass index ≤40 kg/m2;
  • 8. QTcF interval ≤450 msec for male subjects and ≤470 msec for females on ECG at the screening;
  • 9. For women of child-bearing potential: negative result of the serum pregnancy test performed at the screening;
  • 10. The consent of a woman of child-bearing potential, as well as of a man who has female partners of child-bearing potential, to abstain from sexual intercourses or to use effective birth control methods throughout the entire study period and for 60 days after RPH-104 administration (if RPH-104 is administered);
  • 11. The patient is able to fulfil the requirements of the Study Protocol as judged by the Investigator

Exclusion Criteria:

  • 1. The patient received therapy with ibuprofen in a dose of up to 400 mg inclusive within 4 hours or >400 mg within 8 hours prior to randomization.
  • 2. The patient received therapy with diclofenac in a dose of up to 50 mg inclusive within 8 hours or >50 mg within 24 hours prior to randomization.
  • 3. The patient received any other non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to the randomization;
  • 4.The patient received opioids within 48 hours prior to the randomization;
  • 5. The patient received metamizole or metamizole-containing drugs within 12 hours prior to the randomization;
  • 6. The patient received any drug with analgesic activity (including paracetamol) within 6 hours prior to the randomization;
  • 7. The patient received a long-acting NSAID (half-life ≥24 hours) within 5 half-life periods or 1 month prior to the randomization whichever is longer;
  • 8. The patient received naproxen, meloxicam, nabumetone, celecoxib, etoricoxib or extended-release indomethacin within 5 days prior to the randomization;
  • 9 . The patient received corticosteroids (including their intra-articular administration and inhalations) within 4 weeks prior to the randomization;
  • 10. The patient received colchicine within 7 days prior to the randomization;
  • 11. Intolerance or contraindications for NSAID use;
  • 12. Contraindications for the use of Ortanol® capsules 20 mg;
  • 13. Chronic heart failure functional class II-IV (classification of NYHA);
  • 14. History of clinically significant ventricular arrhythmias or clinically significant atrial tachy-arrhythmias or presence of these arrhythmias at the moment of evaluation;
  • 15. Unstable angina or stable exercise-induced angina of functional class III or IV;
  • 16. Secondary gout, chemotherapy-induced gout, lead- or transplantation-induced gout;
  • 17. Rheumatoid arthritis, confirmed or suspected infectious septic arthritis or any other type of acute inflammatory arthritis;
  • 18. Clinically significant renal impairment determined based on creatinine clearance (estimated using the Cockcroft-Gault equation) <60 mL/min, or patients on hemodialysis;
  • 19. Blood coagulation disorders; history of gastrointestinal bleedings or perforation;
  • 20. Pregnant or nursing women;
  • 21. Scheduled surgical treatment or performed major surgical procedure (minor surgical procedures, such as catheter placement are not considered non-inclusion criteria) within 14 days prior to the first dose of the test drug;
  • 22. Current or suspected HIV-infection, HBsAg, Hepatitis C Virus antibodies (HCVAb), other acute or chronic bacterial, fungal or viral infections at the moment of subject's enrolment to the study;
  • 23. Presence of any risk factors for tuberculosis based on the results of assessment using Tuberculosis Risk Assessment Questionnaire at the screening or confirmed tuberculosis or any other infectious disease of the lungs or bronchi based on findings of the chest X-ray exam in two views performed within 3 months prior to the screening visit, or the need for using therapy with tuberculosis medications, such as isoniazid in the course of the study;
  • 24. Neutropenia, leukopenia, or thrombocytopenia determined based on the following laboratory parameters assessed during the screening:

    1. Absolute neutrophil count (ANC) <1.5 x 10^9/L;
    2. White blood cell count <4.0 х 10^9/L
    3. Platelet count <150 х 10^9/L;
  • 25. Immunization with live vaccines within 3 months prior to the subject's enrolment to the study or planned vaccination within 60 days after the expected date of the first dose of the test drug;
  • 26. History of allergic reactions to biologicals, Voltaren® (diclofenac) or Ortanol® (omeprazole);
  • 27. Contraindications for subcutaneous, intramuscular, intravenous or intra-articular injections;
  • 28. History of malignancy (except for patients with localized in situ basal cell carcinoma of the skin or in situ cervical cancer, who can be enrolled to the study immediately after the therapy for this disease), unless it is in remission for ≥5 years, as well as patients who are being examined for cancer or patients with suspected malignancy;
  • 29. A condition or disease, which, in the Investigator's opinion, could put the patient's safety at risk or affect the test drug safety assessment;
  • 30. Any other conditions and diseases, such as uncontrolled diabetes mellitus, uncontrolled hypertension, congestive heart failure, exacerbation of peptic ulcer disease, clinically significant liver diseases, kidney diseases, uncontrolled thyroid dysfunction, unhealed wounds, ulcers or bone fractures, psychiatric disorders, uncontrolled epilepsy, drug dependence, which could prevent the patient from complying with the requirements of this Study Protocol.
  • 31. The patient received biologicals or investigational medicinal products within 5 half-life periods of these drugs or 3 month prior to the randomization whichever is longer;
  • 32. Blood donation or blood loss of ≥400 mL within 8 weeks prior to the randomization.
  • 33. The patient has already been randomized in this clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067492


Locations
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Russian Federation
Moscow City State Healthcare Institution "O.M. Filatov Municipal Clinical Hospital No. 15" of the Moscow Department of Healthcare Recruiting
Moscow, Russian Federation, 111539
Contact: Ivan G. Gordeev    +7 (495) 918 72 84    cardio-15@yandex.ru   
Principal Investigator: Ivan G. Gordeev         
State Budgetary Healthcare Institution of Moscow City "Municipal Clinical Hospital No.1 named after N.I. Pirogov" of Moscow Department of Healthcare Recruiting
Moscow, Russian Federation, 119049
Contact: Evgeniya I. Shmidt    +7 (495) 536 92 33    jenny.smidt@gmail.ru   
Principal Investigator: Evgeniya I. Shmidt         
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) Suspended
Moscow, Russian Federation, 119991
State Budgetary Healthcare Institution of Moscow City "Municipal Clinical Hospital No.52" of Moscow Department of Healthcare Recruiting
Moscow, Russian Federation, 123182
Contact: Natalia G. Poteshkina    +7 (910) 442 22 16    podagra2019@mail.ru   
Principal Investigator: Natalia G. Poteshkina         
State Budgetary Institution of Healthcare of Nizhny Novgorod region "City Clinical hospital #13 of Avozavodskiy district" Recruiting
Nizhny Novgorod, Russian Federation, 603018
Contact: Galina V. Shestakova    +7 (831) 255 67 71    gvshestakova@yandex.ru   
Principal Investigator: Galina V. Shestakova         
Federal State Budgetary Education Institution of Higher Education "Orenburg State Medical University" under Ministry of Healthcare of Russian Federation Recruiting
Orenburg, Russian Federation, 460000
Contact: Oga V. Bugrova    +7(3532) 76 58 42    ov.bugrova@yandex.ru   
Principal Investigator: Olga V. Bugrova         
St. Petersburg State Budgetary Healthcare Institution "Clinical Rheumatological Hospital No.25" Recruiting
Saint Petersburg, Russian Federation, 190068
Contact: Marianna S. Petrova    +7 (812) 310 99 24    podagra@bk.ru   
Principal Investigator: Marianna S. Petrova         
State Budget Institution "Saint Petersburg Research Insitute of emergency care named after I.I. Dzhanelidze Recruiting
Saint Petersburg, Russian Federation, 192242
Contact: Anton S. Povzun    +7(812) 709 61 57    a.s.povzun@gmail.com   
Principal Investigator: Anton S. Povzun         
Limited Liability company "Scientific Research Center Eco-safety" Recruiting
Saint Petersburg, Russian Federation, 196143
Contact: Konstantin A. Zakharov    +7(812) 500 52 03    letuchih_as@ecosafety.ru   
Principal Investigator: Konstantin A. Zakharov         
State Insitution of healthcare "Tula regional clinical dermatovenerologic dispensary" Recruiting
Tula, Russian Federation, 300053
Contact: Valentina N. Sorotskaya    +7(4872) 48 66 21    svnreum1@rambler.ru   
Principal Investigator: Valentina N. Sorotskaya         
State Autonomous Healthcare Institution of the Yaroslavl Region "N.V. Solovyev Clinical Emergency Hospital" Recruiting
Yaroslavl, Russian Federation, 150003
Contact: Olga B. Ershova    +7 (4852) 73 71 03    yarosteoporosis@list.ru   
Principal Investigator: Olga B. Ershova         
Sponsors and Collaborators
R-Pharm
Covance
ZAO Unimed Laboratories
Data Matrix Solutions
Investigators
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Study Director: Mikhail Samsonov R-Pharm

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Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT04067492     History of Changes
Other Study ID Numbers: CL04018054
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by R-Pharm:
hyperuricemia
acute arthritis
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action