Morton's NeuromaEarly Phase 1NCT01298310
A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
A Early Phase 1 study testing Xylocaine in people with Morton's Neuroma, run by AstraZeneca at 1 site in Sweden.
Trial summary
To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morton's Neuroma
- What is being tested?
- Xylocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to May 2012
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Allergy to lidocaine
- Scars or other dermal conditions on the feet that may interfere with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Three-way Cross-over Single Center Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
Read the detailed description
A randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with Morton's Neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
- Conditions
- Morton's Neuroma
- Being tested
- Xylocaine, Placebo
- Keywords
- Morton's neuroma, QST measurements
- Medical subject headings
- Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylocaineDrug
1 mg/mL solution for injection
XylocaineDrug
10 mg/mL solution for injection
PlaceboDrug
solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine_1mg | Active comparator | 1 injection of Xylocaine (1 mg/mL) Receives: Drug: Xylocaine |
| Xylocaine_10mg | Active comparator | 1 injection of Xylocaine (10 mg/mL) Receives: Drug: Xylocaine |
| Placebo | Placebo comparator | 1 injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After drug injection at Day 28 (+/-18).
Secondary outcomes (4)
Frequency/severity of adverse events
Measured: Day 1
Frequency/severity of adverse events
Measured: Day 14 (+/-9)
Frequency/severity of adverse events
Measured: Day 28 (+/-18)
Frequency/severity of adverse events
Measured: Day 43 (+/-32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morton's NeuromaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bror Jonzon, MD, PhD, Study director, AstraZeneca R&D Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298310
- Sponsor's protocol ID
- D2285M00032
- Other IDs
- Eudract no: 2010-024295-26
- Status last verified
- May 2012
- First submitted
- 16 Feb 2011
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Three-way Cross-over Single Center Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
- ClinicalTrials.gov ID
- NCT01298310
- Acronym / sponsor ID
- D2285M00032
- Conditions
- Morton's Neuroma
- Keywords
- Morton's neuroma, QST measurements
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Feb 2011 (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.
To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
Detailed description
A randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with Morton's Neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xylocaine_1mg | Active comparator | Drug: Xylocaine1 injection of Xylocaine (1 mg/mL) |
| Xylocaine_10mg | Active comparator | Drug: Xylocaine1 injection of Xylocaine (10 mg/mL) |
| Placebo | Placebo comparator | Drug: Placebo1 injection of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Allergy to lidocaine
- Scars or other dermal conditions on the feet that may interfere with study procedures
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 |
|---|---|---|
| Xylocaine1 mg/mL solution for injection | Drug | Xylocaine_1mg |
| Xylocaine10 mg/mL solution for injection | Drug | Xylocaine_10mg |
| Placebosolution for injection | Drug | Placebo |
Primary outcome
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: After drug injection at Day 28 (+/-18).
4 secondary outcomes
Frequency/severity of adverse events
Time frame: Day 1
Frequency/severity of adverse events
Time frame: Day 14 (+/-9)
Frequency/severity of adverse events
Time frame: Day 28 (+/-18)
Frequency/severity of adverse events
Time frame: Day 43 (+/-32)
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 22 May 2012.
Related trials for Morton's Neuroma
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Recruiting
Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
Morton Neuroma
Enrolling by invitation
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
Intermetatarsal Bursitis, Morton Neuroma
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.
Bror Jonzon, MD, PhD study director
AstraZeneca R&D Södertälje, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Xylocaine in people with Morton's Neuroma, run by AstraZeneca at 1 site in Sweden.
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 2 inclusion and 2 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 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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) (time frame: Before and after drug injection at Day 1). The study lists 6 primary outcomes in all. 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 22 May 2012; AzTrials last refreshed its copy on 3 Nov 2026.