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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

ModalitySmall molecule

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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