EMONO for the Treatment of Peripheral Neuropathic Pain

Air Liquide Santé International287 enrolled

Overview

To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

287

Conditions

Neuralgia

Interventions

Medical AirDRUG

EMONODRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a mean pain intensity from 4 to 9 as assessed daily with a Numerating Rating Scale during the 7 day period preceding inclusion in spite of administration of usual pain treatments. * Neuropathic pain lasting for more than 3 months but less than 10 years * Definite or probable peripheral neuropathy Exclusion Criteria: * legal incapacity * patient with another concomitant chronic pain * ongoing major depression * Chemotherapy-induced peripheral neuropathic pain

Locations (22)

CHU de Grenoble

Grenoble, La Tronche, France

Centre Hospitalier de Bayeux

Bayeux, France

Outcomes

Primary Outcomes

Pain intensity

Numeric Rating Scale (NRS)

Time frame: 7 days after the last administration of treatment

Secondary Outcomes

Pain intensity

Numeric Rating Scale (NRS)

Time frame: 28 days after the last administration of treatment

Pain characteristic

Neuropathic Pain Symptom Inventory (NPSI)

Time frame: 28 days after the last administration of treatment

Quality of life questionnaire

Medical Outcome Study Short Form (SF-12)

Time frame: 28 days after the last administration of treatment

Number of patients with adverse events

Time frame: through study duration, up to 31 days

Data from ClinicalTrials.gov

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