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Completed

NCT Number: NCT01298310

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

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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Key information

Conditions

Morton's Neuroma Foot Diseases Joint Diseases Metatarsalgia Morton Neuroma Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site

Stockholm, Sweden

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylocaine

Drug

1 mg/mL solution for injection

Placebo

Drug

solution for injection

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2011
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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