Back to resultsA Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
Primary Purpose
Morton's Neuroma
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Xylocaine
Xylocaine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Morton's Neuroma focused on measuring Morton's neuroma, QST measurements
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Xylocaine_1mg
Xylocaine_10mg
Placebo
Arm Description
1 injection of Xylocaine (1 mg/mL)
1 injection of Xylocaine (10 mg/mL)
1 injection of placebo
Outcomes
Primary Outcome Measures
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 Measures
Frequency/severity of adverse events
Frequency/severity of adverse events
Frequency/severity of adverse events
Frequency/severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01298310
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morton's Neuroma
Keywords
Morton's neuroma, QST measurements
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xylocaine_1mg
Arm Type
Active Comparator
Arm Description
1 injection of Xylocaine (1 mg/mL)
Arm Title
Xylocaine_10mg
Arm Type
Active Comparator
Arm Description
1 injection of Xylocaine (10 mg/mL)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 injection of placebo
Intervention Type
Drug
Intervention Name(s)
Xylocaine
Intervention Description
1 mg/mL solution for injection
Intervention Type
Drug
Intervention Name(s)
Xylocaine
Intervention Description
10 mg/mL solution for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
solution for injection
Primary Outcome Measure Information:
Title
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)
Time Frame
Before and after drug injection at Day 1
Title
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)
Time Frame
Before and after drug injection at Day 14 (+/-9).
Title
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)
Time Frame
Before and after drug injection at Day 28 (+/-18).
Title
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)
Time Frame
After drug injection at Day 1.
Title
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)
Time Frame
After drug injection at Day 14 (+/-9).
Title
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)
Time Frame
After drug injection at Day 28 (+/-18).
Secondary Outcome Measure Information:
Title
Frequency/severity of adverse events
Time Frame
Day 1
Title
Frequency/severity of adverse events
Time Frame
Day 14 (+/-9)
Title
Frequency/severity of adverse events
Time Frame
Day 28 (+/-18)
Title
Frequency/severity of adverse events
Time Frame
Day 43 (+/-32)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bror Jonzon, MD, PhD
Organizational Affiliation
AstraZeneca R&D Södertälje, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
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