EMONO for the Treatment of Peripheral Neuropathic Pain | NCT02957851

Studies
EMONO for the Treatment of Peripheral Neuropathic Pain

NCT02957851

Sponsor

Air Liquide Santé International

Status

Completed

Last Update Posted

Sep 21, 2018Actual

Enrollment

287Actual

Phase

Phase 2

Conditions

Neuralgia

Interventions

Medical Air
EMONO

Countries

France
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Aug 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Nov 4, 2016

First Posted Date

Nov 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2018

Last Update Posted Date

Sep 21, 2018Actual

Name	Class
AMS Advanced Medical Services GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxygen/Nitrogen (22%/78%)	Placebo Comparator	Medical Air	Drug: Medical Air
Nitrous Oxide/Oxygen (50%/50%)	Active Comparator	EMONO	Drug: EMONO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Air	Drug		Oxygen/Nitrogen (22%/78%)	Oxygen/Nitrogen
EMONO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity	Numeric Rating Scale (NRS)	7 days after the last administration of treatment

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity	Numeric Rating Scale (NRS)	28 days after the last administration of treatment
Pain characteristic	Neuropathic Pain Symptom Inventory (NPSI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Didier Bouhassira, MD	Hospital Ambroise Paré Paris	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Grenoble		Grenoble	La Tronche	38700	France
Centre Hospitalier de Bayeux

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35050957	Derived	Bouhassira D, Perrot S, Attal N, Ramirez-Gil JF, Delval C, Schaller M, Bessiere B, Houeto P, Sommer C. Combination of inhaled nitrous oxide and oral opioids induces long-lasting analgesic effects in patients with neuropathic pain: ProtoTOP study post hoc exploratory analyses. Pain. 2022 Sep 1;163(9):e1021-e1029. doi: 10.1097/j.pain.0000000000002570. Epub 2021 Dec 20.
33044394

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

ID	Term
D001272	Atmosphere
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena

ID	Term
D000388	Air
D010100	Oxygen
D009584	Nitrogen
D009609	Nitrous Oxide