NCT02957851CompletedPhase 2
Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study
Air Liquide Santé International22 sites in 2 countries287 target enrollmentStarted: November 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 287
- Locations
- 22
- Primary Endpoint
- Pain intensity
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Oxygen/Nitrogen (22%/78%)
Placebo Comparator
Medical Air
Intervention: Medical Air (Drug)
Nitrous Oxide/Oxygen (50%/50%)
Active Comparator
EMONO
Intervention: EMONO (Drug)
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 7 days after the last administration of treatment
Numeric Rating Scale (NRS)
Secondary Outcomes
- Pain intensity(28 days after the last administration of treatment)
- Pain characteristic(28 days after the last administration of treatment)
- Quality of life questionnaire(28 days after the last administration of treatment)
- Number of patients with adverse events(through study duration, up to 31 days)
Investigators
Study Sites (22)
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