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
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Morton's Neuroma
Intervention: Xylocaine (Drug); Xylocaine (Drug); Placebo (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Bror Jonzon, MD, PhD, Study Director, Affiliation: AstraZeneca R&D Södertälje, Sweden
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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 eventsFrequency/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
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Stockholm, Sweden; Recruiting
Additional Information
Starting date: February 2011
Last updated: November 21, 2011
|
