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

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ClinicalTrials.gov Identifier: NCT01967550
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: diclofenac diethylamine, DDEA 2.32% gel Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 4-week, Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Assess the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel for the Relief of Signs and Symptoms in Patients With Knee Osteoarthritis
Study Start Date : October 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel
Drug: diclofenac diethylamine, DDEA 2.32% gel
Placebo Comparator: Placebo
Vehicle control
Drug: Placebo



Primary Outcome Measures :
  1. Measure: Pain On Movement (POM) [ Time Frame: 2 weeks ]
    POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT01967550


Locations
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Germany
Bad Hersfeld, Germany
Berlin, Germany
Hamburg, Germany
Munich, Germany
Stockach, Germany
Sponsors and Collaborators
Novartis

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01967550     History of Changes
Other Study ID Numbers: 194-P-308
2012-004024-38 ( EudraCT Number )
First Posted: October 23, 2013    Key Record Dates
Results First Posted: June 3, 2015
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Novartis:
Symptomatic knee OA Kellgren-Lawrence grade 1-3

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic 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