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ALGRX 4975 in the Treatment of Patients With Morton's Neuroma

Primary Purpose

Neuroma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALGRX 4975
Sponsored by
AlgoRx Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroma focused on measuring Intermetatarsal neuroma, Morton's neuroma, ALGRX 4975, capsaicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Crossroads Research, Inc.
  • Jean Brown Research

Outcomes

Primary Outcome Measures

Weekly average foot pain severity scores

Secondary Outcome Measures

The sum of weekly average foot pain severity scores
Interference item scores of the Brief Pain Inventory
Weekly number of analgesic units taken

Full Information

First Posted
August 15, 2005
Last Updated
September 30, 2005
Sponsor
AlgoRx Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00130962
Brief Title
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AlgoRx Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
Subjects will have painful primary or post-operative intermetatarsal neuroma. Each subject will be randomly allocated to receive either ALGRX 4975 or placebo in a 1:1 ratio. Study drug or placebo will be injected into the intermetatarsal space containing a painful neuroma. Subjects will complete weekly assessments for the Average Foot Pain Severity, the 7 Interference Items of the BPI, and the number of analgesic units taken. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment. Plasma concentrations will be assessed pre-dose and post dose at 5, 10, 15, 20, 30, and 45 min and at 1, 1.5, 2, 2.5, 3 and 4 hours. Safety will be assessed at baseline and during the study with adverse events (all visits), vital signs (Visit 2 pre and post-injection and Visit 3 or at early termination), and laboratory assessments (hematology, chemistry, urinalysis) and ECG (Screening and Visit 3 or at early termination). The injection site will be examined and assessed by a 6-point scale for erythema, edema, and hemorrhage before the injection and at 1, 2 and 4 hours after the injection. A pain on injection NRS will be assessed immediately post- injection at 15, 30, and 45 minutes and 1, 2, 3, and 4 hours after study drug administration. A sensory examination of the foot will be performed before the injection and 4 hours after the injection and at the completion of the study. If a subject has injection pain, the foot may be wrapped in ice for up to 20 minutes, analgesic medication may be provided.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroma
Keywords
Intermetatarsal neuroma, Morton's neuroma, ALGRX 4975, capsaicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ALGRX 4975
Primary Outcome Measure Information:
Title
Weekly average foot pain severity scores
Secondary Outcome Measure Information:
Title
The sum of weekly average foot pain severity scores
Title
Interference item scores of the Brief Pain Inventory
Title
Weekly number of analgesic units taken

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Diamond, D.P.M.
Organizational Affiliation
Crossroads Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Crossroads Research, Inc.
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

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ALGRX 4975 in the Treatment of Patients With Morton's Neuroma

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