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)
Sponsor study identifier
Secondary identifiers
interventional
27
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 16, 2011
Actual (reported)February 17, 2011
Actual (reported)May 2012
Actual (reported)May 2012
Actual (reported)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)
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)
1 injection of Xylocaine (1 mg/mL)
1 injection of Xylocaine (10 mg/mL)
1 injection of placebo
1 mg/mL solution for injection
10 mg/mL solution for injection
Research Site
Stockholm, Sweden
Bror Jonzon, MD, PhD
AstraZeneca R&D Södertälje, Sweden
27 participants (actual enrollment reported by the registry).
First Submitted
February 16, 2011
First Posted
February 17, 2011
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
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).
solution for injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
May 22, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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