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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Morton's Neuroma

Intervention: Xylocaine (Drug); Xylocaine (Drug); Placebo (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bror Jonzon, MD, PhD, Study Director, Affiliation: AstraZeneca R&D Södertälje, Sweden

Summary

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

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome:

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)

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)

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)

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)

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)

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)

Secondary outcome:

Frequency/severity of adverse events

Frequency/severity of adverse events

Frequency/severity of adverse events

Frequency/severity of adverse events

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)

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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 and Contacts

Research Site, Stockholm, Sweden
Additional Information

Starting date: February 2011
Last updated: May 21, 2012

Page last updated: August 23, 2015

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