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Xylocaine

Phase 1

Morton's Neuroma | Small molecule | Musculoskeletal |AstraZeneca PLC|Last Updated: May 22, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Xylocaine · 1 trial · 1 indication

Early Phase 1 1
NCT01298310A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)Morton's Neuroma
COMPLETED27 Analytics
EARLY_PHASE1COMPLETED
A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
Morton's Neuroma
NCT0129831027
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Study Endpoints

Primary Endpoints

The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
Before and after drug injection at Day 1
The effect of Xylocaine compared to placebo in QST variables. Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
After drug injection at Day 1.

Secondary Endpoints

Frequency/severity of adverse events
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Xylocaine_1mgACTIVE_COMPARATOR1 injection of Xylocaine (1 mg/mL)
Xylocaine_10mgACTIVE_COMPARATOR1 injection of Xylocaine (10 mg/mL)
PlaceboPLACEBO_COMPARATOR1 injection of placebo

Interventions

NameTypeDescription
XylocaineDRUG1 mg/mL solution for injection
PlaceboDRUGsolution for injection
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with a clinical diagnosis of Morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot) * Visual analogue scale (VAS) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1) Exclusion Criteria: *...

Countries:Sweden
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Frequently asked questions about Xylocaine

What is Xylocaine used for in Morton's Neuroma?

Xylocaine is a small molecule being studied for use in Morton's Neuroma, a painful condition affecting the foot. It is administered locally to explore its effect on the condition. The drug is currently in early Phase 1 clinical development and remains investigational, not yet approved for this indication.

Who makes Xylocaine?

Xylocaine is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The company is conducting clinical research to evaluate the drug's potential in treating Morton's Neuroma.

What phase is Xylocaine in?

Xylocaine is in early Phase 1 clinical development for Morton's Neuroma. It is an investigational drug, meaning it has not been approved by regulatory authorities. The clinical trial for this indication has been completed, with results not yet reported.

What clinical trials is Xylocaine in?

Xylocaine has one completed clinical trial, identified as NCT01298310, titled 'A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)'. This early Phase 1 trial enrolled 27 participants in Sweden and was placebo-controlled, randomized, and double-blind.

Is Xylocaine the same as lidocaine?

Yes, Xylocaine is also known as lidocaine. The clinical trial for Morton's Neuroma explicitly refers to Xylocaine as lidocaine, indicating the two names refer to the same drug substance. This is important for readers searching under either name.