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Osteoarthritis, Knee | Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)

Osteoarthritis, Knee research study

What is the primary objective of this study?

This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).

Who is eligible to participate?

Inclusion Criteria: - 1. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 5. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study Exclusion Criteria: - 1. Partial or total replacement of either knee joint, past or planned/expected during study duration. 2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician; 4. Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Osteoarthritis, Knee

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:diclofenac diethylamine, DDEA 2.32% gel

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

diclofenac diethylamine, DDEA 2.32% geldiclofenac diethylamine, DDEA 2.32% gel

PlaceboVehicle control

Study Status

Completed

Start Date: October 2013

Completed Date: May 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Measure: Pain On Movement (POM)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Novartis

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01967550

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