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

AstraZeneca

Status and phase: Completed; Early Phase 1

Conditions: Morton's Neuroma

Treatments: Drug: Xylocaine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298310

D2285M00032

Eudract no: 2010-024295-26

Details and patient eligibility

About

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

Full 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)

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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27 participants in 3 patient groups, including a placebo group

Xylocaine_1mg

Active Comparator group

Description:

1 injection of Xylocaine (1 mg/mL)

Treatment:

Drug: Xylocaine

Drug: Xylocaine

Xylocaine_10mg

Active Comparator group

Description:

1 injection of Xylocaine (10 mg/mL)

Treatment:

Drug: Xylocaine

Drug: Xylocaine

Placebo

Placebo Comparator group

Description:

1 injection of placebo

Treatment:

Drug: Placebo