EMONO for the Treatment of Peripheral Neuropathic Pain

NCT02957851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2018-09-21

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957851 on ClinicalTrials.gov