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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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ClinicalTrials.gov Identifier: NCT01298310
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : May 22, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Morton's Neuroma Drug: Xylocaine Drug: Placebo Early Phase 1

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : February 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Xylocaine_1mg
1 injection of Xylocaine (1 mg/mL)
Drug: Xylocaine
1 mg/mL solution for injection

Active Comparator: Xylocaine_10mg
1 injection of Xylocaine (10 mg/mL)
Drug: Xylocaine
10 mg/mL solution for injection

Placebo Comparator: Placebo
1 injection of placebo
Drug: Placebo
solution for injection




Primary Outcome Measures :
  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) [ Time Frame: Before and after drug injection at Day 1 ]
  2. 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). ]
  3. 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). ]
  4. 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. ]
  5. 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). ]
  6. 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 Measures :
  1. Frequency/severity of adverse events [ Time Frame: Day 1 ]
  2. Frequency/severity of adverse events [ Time Frame: Day 14 (+/-9) ]
  3. Frequency/severity of adverse events [ Time Frame: Day 28 (+/-18) ]
  4. Frequency/severity of adverse events [ Time Frame: Day 43 (+/-32) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298310


Locations
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Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Bror Jonzon, MD, PhD AstraZeneca R&D Södertälje, Sweden

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01298310     History of Changes
Other Study ID Numbers: D2285M00032
Eudract no: 2010-024295-26
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012
Keywords provided by AstraZeneca:
Morton's neuroma, QST measurements
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuroma
Morton Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Metatarsalgia
Foot Diseases
Musculoskeletal Diseases
Joint Diseases
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action