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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00130962
• Date of registration: 15/08/2005
• Primary sponsor: AlgoRx Pharmaceuticals
• Public title: ALGRX 4975 in the Treatment of Patients With Morton's Neuroma
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma
• Date of first enrolment: September 2004
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00130962
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Eric Diamond, D.P.M.
• Affiliation: Crossroads Research, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neuroma

Intervention(s)

Drug: ALGRX 4975

Primary Outcome(s)

Weekly average foot pain severity scores

Secondary Outcome(s)

Interference item scores of the Brief Pain Inventory

The sum of weekly average foot pain severity scores

Weekly number of analgesic units taken

Secondary ID(s)

4975-2-004-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors