NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

Danish Pain Research Center18 enrolled

Overview

Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

NS1209DRUG

LidocaineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

- Spontaneous ongoing pain intensity (VAS 0-100)

Secondary Outcomes

Number of responders (at least 33% pain reduction)

Effect on evoked allodynia (VAS 0-100)

Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)

Feeling of unpleasantness (VAS 0-100)

Pain on movements (VAS 0-100)

Daily pain (NSP 0-10)

Data from ClinicalTrials.gov

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