A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)

Early Phase 1CompletedNCT01298310

AstraZeneca27 enrolled

Overview

To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

A randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with Morton's Neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Morton's Neuroma

Interventions

XylocaineDRUG

1 mg/mL solution for injection

XylocaineDRUG

10 mg/mL solution for injection

PlaceboDRUG

solution for injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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: * Allergy to lidocaine * Scars or other dermal conditions on the feet that may interfere with study procedures

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

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)

Time frame: Before and after drug injection at Day 1

Time frame: Before and after drug injection at Day 14 (+/-9).

Time frame: Before and after drug injection at Day 28 (+/-18).

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)

Time frame: 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)

Time frame: After drug injection at Day 14 (+/-9).

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)

Time frame: After drug injection at Day 28 (+/-18).

Secondary Outcomes

Frequency/severity of adverse events

Data from ClinicalTrials.gov

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