NCT01298310

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

February 16, 2011

Last Update Submit

May 21, 2012

Conditions

Morton's Neuroma

Keywords

Morton's neuroma, QST measurements

Outcome Measures

Primary Outcomes (6)

  • 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).

Secondary Outcomes (4)

  • Frequency/severity of adverse events

    Day 1

  • Frequency/severity of adverse events

    Day 14 (+/-9)

  • Frequency/severity of adverse events

    Day 28 (+/-18)

  • Frequency/severity of adverse events

    Day 43 (+/-32)

Study Arms (3)

Xylocaine_1mg

ACTIVE COMPARATOR

1 injection of Xylocaine (1 mg/mL)

Drug: Xylocaine

Xylocaine_10mg

ACTIVE COMPARATOR

1 injection of Xylocaine (10 mg/mL)

Drug: Xylocaine

Placebo

PLACEBO COMPARATOR

1 injection of placebo

Drug: Placebo

Interventions

XylocaineDRUG

1 mg/mL solution for injection

Xylocaine_1mg
PlaceboDRUG

solution for injection

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Allergy to lidocaine
  • Scars or other dermal conditions on the feet that may interfere with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Morton Neuroma

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

MetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Bror Jonzon, MD, PhD

    AstraZeneca R&D Södertälje, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 22, 2012

Record last verified: 2012-05

Locations

SE(1)