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 1

Completed

• Conditions: Morton's Neuroma
• Interventions: Drug: Xylocaine; Drug: Placebo

• Registration Number: NCT01298310
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xylocaine_1mg	Xylocaine	1 injection of Xylocaine (1 mg/mL)
Xylocaine_10mg	Xylocaine	1 injection of Xylocaine (10 mg/mL)
Placebo	Placebo	1 injection of placebo

Primary Outcome Measures

Name	Time	Method
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 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)	After drug injection at Day 28 (+/-18).

Secondary Outcome Measures

Name	Time	Method
Frequency/severity of adverse events	Day 43 (+/-32)

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden