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

Morton's Neuroma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298310
• Other study ID #: D2285M00032
• Secondary ID: Eudract no: 2010
• Status: Completed
• Phase: Phase 0
• First received: February 16, 2011
• Last updated: May 21, 2012
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Morton's Neuroma
• Neuroma

Intervention

Drug:
• Xylocaine
1 mg/mL solution for injection
• Xylocaine
10 mg/mL solution for injection
• Placebo
solution for injection

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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).	No
Primary	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).	No
Primary	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.	No
Primary	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).	No
Primary	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).	No
Secondary	Frequency/severity of adverse events		Day 1	Yes
Secondary	Frequency/severity of adverse events		Day 14 (+/-9)	Yes
Secondary	Frequency/severity of adverse events		Day 28 (+/-18)	Yes
Secondary	Frequency/severity of adverse events		Day 43 (+/-32)	Yes