Clinical trial NCT04421911: A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac
Official title: A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: ketoprofen
diclofenac
osteoarthritis
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 236
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean change in walking arthritis pain intensity score
timeFrame: 3 weeks
Secondary outcomes:
measure: Mean change in spontaneous arthritis pain intensity score
timeFrame: 3 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 3 weeks
measure: Global Impression of Improvement (PGI-I)
timeFrame: 3 weeks
measure: Adverse events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Maksimum Zdorovya
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #1 n.a. Pirogova
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University n.a. I.P.Pavlov
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I.Razumovsky
city: Smolensk
country: Russian Federation
facility: Private Healthcare Institution Smolensk Russian Railway Clinical Hospital
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital n.a. N.V.Soloviev
Study officials:
References: