A Study 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)

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

Study Overview

• Status: Completed
• Conditions: Morton's Neuroma
• Intervention / Treatment: Drug: Placebo; Drug: Xylocaine; Drug: Xylocaine

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Xylocaine_1mg; 1 injection of Xylocaine (1 mg/mL)	Drug: Xylocaine; 1 mg/mL solution for injection; Drug: Xylocaine; 10 mg/mL solution for injection
ACTIVE_COMPARATOR: Xylocaine_10mg; 1 injection of Xylocaine (10 mg/mL)	Drug: Xylocaine; 1 mg/mL solution for injection; Drug: Xylocaine; 10 mg/mL solution for injection
PLACEBO_COMPARATOR: Placebo; 1 injection of placebo	Drug: Placebo; solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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 14 (+/-9).
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 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 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)	After drug injection at Day 28 (+/-18).

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency/severity of adverse events	Day 1
Frequency/severity of adverse events	Day 14 (+/-9)
Frequency/severity of adverse events	Day 28 (+/-18)
Frequency/severity of adverse events	Day 43 (+/-32)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Bror Jonzon, MD, PhD, AstraZeneca R&D Sodertalje, Sweden

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (ESTIMATE): February 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Morton's neuroma, QST measurements
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Neuralgia; Nerve Sheath Neoplasms; Metatarsalgia; Neuroma; Morton Neuroma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: D2285M00032; Eudract no: 2010-024295-26