Clinical trial NCT01298310: A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Morton's Neuroma
Keywords: Morton's neuroma, QST measurements
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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)

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Before and after drug injection at Day 1
measure: 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)
timeFrame: Before and after drug injection at Day 14 (+/-9).
measure: 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)
timeFrame: Before and after drug injection at Day 28 (+/-18).
measure: 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)
timeFrame: After drug injection at Day 1.
measure: 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)
timeFrame: After drug injection at Day 14 (+/-9).
measure: 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)
timeFrame: After drug injection at Day 28 (+/-18).
Secondary outcomes:
measure: Frequency/severity of adverse events
timeFrame: Day 1
measure: Frequency/severity of adverse events
timeFrame: Day 14 (+/-9)
measure: Frequency/severity of adverse events
timeFrame: Day 28 (+/-18)
measure: Frequency/severity of adverse events
timeFrame: Day 43 (+/-32)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje, Sweden
name: Bror Jonzon, MD, PhD
role: STUDY_DIRECTOR
References: