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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01298310
First received: February 16, 2011
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Morton's Neuroma
Drug: Xylocaine
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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) [ Time Frame: Before and after drug injection at Day 1 ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency/severity of adverse events [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Frequency/severity of adverse events [ Time Frame: Day 14 (+/-9) ] [ Designated as safety issue: Yes ]
  • Frequency/severity of adverse events [ Time Frame: Day 28 (+/-18) ] [ Designated as safety issue: Yes ]
  • Frequency/severity of adverse events [ Time Frame: Day 43 (+/-32) ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298310

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01298310     History of Changes
Other Study ID Numbers: D2285M00032, Eudract no: 2010-024295-26
Study First Received: February 16, 2011
Last Updated: May 21, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Morton's neuroma, QST measurements

Additional relevant MeSH terms:
Neuroma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014