EMONO for the Treatment of Peripheral Neuropathic Pain
NCT02957851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287
Last updated 2018-09-21
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
Conditions
- Neuralgia
Interventions
- DRUG
-
Medical Air
- DRUG
-
EMONO
Sponsors & Collaborators
-
AMS Advanced Medical Services GmbH
collaborator INDUSTRY -
Air Liquide Santé International
lead INDUSTRY
Principal Investigators
-
Didier Bouhassira, MD · Hospital Ambroise Paré Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- France
- Germany
Study Locations
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