A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac
A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis
1 other identifier
interventional
236
1 country
9
Brief Summary
Primary objective:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score Secondary objectives:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints.
- To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2020
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedFirst Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 20, 2021
January 1, 2021
6 months
June 2, 2020
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in walking arthritis pain intensity score
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
3 weeks
Secondary Outcomes (4)
Mean change in spontaneous arthritis pain intensity score
3 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
3 weeks
Global Impression of Improvement (PGI-I)
3 weeks
Adverse events
3 weeks
Study Arms (2)
ketoprofen
EXPERIMENTALDiclofenac
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients aged 40-75 years
- Compliance to ACR diagnostic criteria of OA of the knee
- Patients with Kellgren-Lawrence grade 1-3
- Index knee pain should be ≥40 mm on VAS (100mm) scale
You may not qualify if:
- Intolerance or allergic reactions to the study therapy
- Usage of NSAIDs within 3 days
- Open skin lesions or dermatological conditions at the site of plaster application
- Surgery or major trauma of the index knee within the previous 12 months
- Pregnant or breast-feeding women
- Alcohol addiction, drug addiction or drug abuse in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Handok Inc.lead
Study Sites (9)
Maksimum Zdorovya
Kemerovo, Russia
City Clinical Hospital #1 n.a. Pirogova
Moscow, Russia
Rostov State Medical University
Rostov-on-Don, Russia
Ryazan State Medical University n.a. I.P.Pavlov
Ryazan, Russia
Saratov State Medical University n.a. V.I.Razumovsky
Saratov, Russia
Private Healthcare Institution Smolensk Russian Railway Clinical Hospital
Smolensk, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia
Regional Clinical Hospital
Vladimir, Russia
Clinical Emergency Hospital n.a. N.V.Soloviev
Yaroslavl, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 9, 2020
Study Start
March 20, 2020
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share