Pain
Conditions
Keywords
Peripheral neuropathic pain, Neuropathic pain, Chronic pain
Brief summary
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.
Interventions
DRUGNS1209
DRUGLidocaine
Sponsors
NeuroSearch A/S
Danish Pain Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Neuropathic pain and allodynia after a peripheral nerve injury (VAS \>= 4)
Exclusion criteria
* Patients who cannot cooperate and do no understand Danish * Fertile women * Clinically significant abnormality or disease * Drug and alcohol abuse * Clinically abnormal ECG * Hypersensitivity to any of the treatments * Patients in treatment with cimetedin, antidepressants, antipsychotics, antiepileptics except gabapentin, anticoagulants, Na channel blockers and beta blockers * Patients who have previously been treated in a NS1209 study * Patients treated with an investigational drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Spontaneous ongoing pain intensity (VAS 0-100) | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on evoked allodynia (VAS 0-100) | — |
| Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse) | — |
| Number of responders (at least 33% pain reduction) | — |
| Pain on movements (VAS 0-100) | — |
| Daily pain (NSP 0-10) | — |
| Feeling of unpleasantness (VAS 0-100) | — |
Countries
Denmark
Outcome results
None listed