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Diclofenac diethylamine 2.32%

Phase 3

Grade I/II Ankle Sprain | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Apr 20, 2012

Target and mechanism

ModalitySmall molecule

Also known as Diclofenac diethylamine 2.32% gel, diclofenac diethylamine gel 2.32%

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment242

FDA Designations

No designations recorded

Clinical trial landscape

Diclofenac diethylamine 2.32% · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00955513Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle SprainGrade I/II Ankle Sprain
COMPLETED242 Analytics
PHASE3COMPLETED
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Grade I/II Ankle SprainUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Pain on Movement on Day 5 (Change From Baseline).
baseline and day 5

Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.

Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
change from baseline (on day 1) to day 5

Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
diclofenac diethylamine gel 2.32% gel twice a dayEXPERIMENTALdrug
diclofenac diethylamine gel 2.32% gel three times a dayEXPERIMENTALdrug
placeboPLACEBO_COMPARATORplacebo
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
diclofenac diethylamine gel 2.32%DRUGdiclofenac diethylamine gel 2.32% twice a day
PlaceboDRUGPlacebo
Diclofenac diethylamine 2.32% gelDRUGDiclofenac diethylamine 2.32% gel twice daily
Diclofenac diethylamine 2.32% gel / PlaceboDRUGDiclofenac diethylamine 2.32% gel once daily / Vehicle once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1\. Acute sprain of the lateral ankle, Grade I-II . Exclusion Criteria: 1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient. 2. Topical analgesic or anti-inflammatory treatment over th...

Countries:Germany
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