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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract no: 2010-024295-26 |
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To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylocaine_1mg | Active Comparator | 1 injection of Xylocaine (1 mg/mL) |
|
| Xylocaine_10mg | Active Comparator | 1 injection of Xylocaine (10 mg/mL) |
|
| Placebo | Placebo Comparator | 1 injection of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine | Drug | 1 mg/mL solution for injection |
| |
| Xylocaine |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency/severity of adverse events | Day 1 | |
| Frequency/severity of adverse events | Day 14 (+/-9) | |
| Frequency/severity of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bror Jonzon, MD, PhD | AstraZeneca R&D Södertälje, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockholm | Sweden |
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| Drug |
10 mg/mL solution for injection |
|
| Placebo | Drug | solution for injection |
|
| Day 28 (+/-18) |
| Frequency/severity of adverse events | Day 43 (+/-32) |
| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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