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diclofenac diethylamine, DDEA 2.32%

Phase 3

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Jun 3, 2015

Target and mechanism

Molecular targetPTGS2, PTGS1
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL139

Also known as diclofenac diethylamine, DDEA 2.32% gel

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment304

FDA Designations

No designations recorded

Clinical trial landscape

diclofenac diethylamine, DDEA 2.32% · 1 trial · 1 indication

Phase 3 1
NCT01967550Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)Osteoarthritis, Knee
COMPLETED304 Analytics
PHASE3COMPLETED
Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Pain On Movement (POM)
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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
diclofenac diethylamine, DDEA 2.32% gelEXPERIMENTALdiclofenac diethylamine, DDEA 2.32% gel
PlaceboPLACEBO_COMPARATORVehicle control

Interventions

NameTypeDescription
diclofenac diethylamine, DDEA 2.32% gelDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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...

Countries:Germany
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Competitive Landscape -Osteoarthritis 115 trials (matched to "Osteoarthritis, Knee")

Frequently asked questions about diclofenac diethylamine, DDEA 2.32%

What is diclofenac diethylamine, DDEA 2.32% used for?

Diclofenac diethylamine, DDEA 2.32% is a topical gel being developed for the treatment of knee osteoarthritis. It is applied to the skin over the affected joint. The asset is in Phase 3 development, and its clinical program has focused on patients with knee osteoarthritis.

What does diclofenac diethylamine, DDEA 2.32% target?

Diclofenac diethylamine, DDEA 2.32% targets the enzymes PTGS2 (cyclooxygenase-2) and PTGS1 (cyclooxygenase-1). It acts as an inhibitor of these targets. This mechanism is the basis for its anti-inflammatory and analgesic activity in musculoskeletal conditions such as knee osteoarthritis.

Who makes diclofenac diethylamine, DDEA 2.32%?

Diclofenac diethylamine, DDEA 2.32% is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this topical gel formulation for knee osteoarthritis.

What phase is diclofenac diethylamine, DDEA 2.32% in?

Diclofenac diethylamine, DDEA 2.32% is in Phase 3 development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial for this asset has been completed.

What clinical trials is diclofenac diethylamine, DDEA 2.32% in?

Diclofenac diethylamine, DDEA 2.32% has been studied in one Phase 3 trial, NCT01967550, titled "Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)." The trial was completed, enrolled 304 patients in Germany, and was randomized, double-blind, and placebo-controlled.

Is diclofenac diethylamine, DDEA 2.32% the same as diclofenac diethylamine, DDEA 2.32% gel?

Yes, diclofenac diethylamine, DDEA 2.32% and diclofenac diethylamine, DDEA 2.32% gel refer to the same product. The gel designation describes the topical formulation of this small molecule asset. Both names identify the same investigational therapy developed by Novartis for knee osteoarthritis.