NCT00130962

Brief Summary

Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or placebo will be injected into the space containing the neuroma. Subjects will complete weekly assessments for severity of foot pain, a brief pain inventory, and the amount of pain medication taken. Subjects will be seen for a screening visit, a treatment visit, and two follow-up visits after treatment. The last scheduled visit is one month after treatment. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 3, 2005

Status Verified

August 1, 2005

First QC Date

August 15, 2005

Last Update Submit

September 30, 2005

Conditions

Neuroma

Keywords

Intermetatarsal neuromaMorton's neuromaALGRX 4975capsaicin

Outcome Measures

Primary Outcomes (1)

  • Weekly average foot pain severity scores

Secondary Outcomes (3)

  • The sum of weekly average foot pain severity scores

  • Interference item scores of the Brief Pain Inventory

  • Weekly number of analgesic units taken

Interventions

ALGRX 4975DRUG

Eligibility Criteria

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

You may qualify if:

  • Males or females aged \>18 years
  • Foot X-ray to rule out alternative pathology, and ultrasound or magnetic resonance imaging (MRI) to confirm the presence of a neuroma within 6 months of study entry
  • Evidence of either a primary or post surgical recurrence neuroma
  • A score of 4 or greater on the Average Foot Pain Severity Numeric Rating Scale (NRS) during the week prior to randomization
  • Failed conservative treatment such as wide shoes, orthotics, arch supports, or oral and/or injected analgesics
  • Signed an Informed Consent form approved by the Institutional Review Board
  • For female subjects: is surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method (as determined by the Principal Investigator) of birth control; if of child-bearing potential is not pregnant (have a documented negative urine pregnancy test prior to enrollment), is not planning to get pregnant (during the time course of the study), or is not lactating
  • Able to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments

You may not qualify if:

  • History of clearly documented allergic reaction to lidocaine or capsaicin.
  • Prior participation in ALGRX 4975 study.
  • Presence of any medical condition or instability that, in the judgment of the Investigator, might adversely impact the conduct of the study and the collection of data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as diabetes mellitus or extensive vascular disease
  • Treatment of neuroma with a narcotic analgesic
  • Other painful foot pathology
  • Active cutaneous, or other disease, at the anticipated site of study drug injection
  • Laboratory results that are both out of normal range and, in the opinion of the Investigator, clinically significant
  • Drug or alcohol abuse within the past 2 years
  • Require regular oral steroid medication, except for stable use (6 months or longer on the same scheduled dose) for mild or moderate asthma
  • Use of an investigational medication in the 30 days prior to the current study or scheduled to receive such an agent while participating in the current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Crossroads Research, Inc.

Owings Mills, Maryland, 21117, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

NeuromaMorton Neuroma

Condition Hierarchy (Ancestors)

Nerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsMetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Diamond, D.P.M.

    Crossroads Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 17, 2005

Study Start

September 1, 2004

Study Completion

February 1, 2006

Last Updated

October 3, 2005

Record last verified: 2005-08

Locations

US(2)