NeuromaPhase 2NCT00130962
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma
A Phase 2 study testing ALGRX 4975 in people with Neuroma, run by AlgoRx Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroma
- What is being tested?
- ALGRX 4975
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Crossroads Research, Inc.
Owings Mills, Maryland, 21117
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma
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.
Read the 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.
- Conditions
- Neuroma
- Being tested
- ALGRX 4975
- Keywords
- Intermetatarsal neuroma, Morton's neuroma, ALGRX 4975, capsaicin
- Medical subject headings
- Neuroma, Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALGRX 4975Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startSep 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- AlgoRx Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Diamond, D.P.M., Principal investigator, Crossroads Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130962
- Sponsor's protocol ID
- 4975-2-004-1
- Status last verified
- Aug 2005
- First submitted
- 15 Aug 2005
- Last updated
- 3 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma
- ClinicalTrials.gov ID
- NCT00130962
- Acronym / sponsor ID
- 4975-2-004-1
- Conditions
- Neuroma
- Keywords
- Intermetatarsal neuroma, Morton's neuroma, ALGRX 4975, capsaicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- AlgoRx PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Feb 2006
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALGRX 4975 | Drug | – |
Primary outcome
Weekly average foot pain severity scores
3 secondary outcomes
The sum of weekly average foot pain severity scores
Interference item scores of the Brief Pain Inventory
Weekly number of analgesic units taken
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Diamond, D.P.M. principal investigator
Crossroads Research, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALGRX 4975 in people with Neuroma, run by AlgoRx Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly average foot pain severity scores. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2005.