Non Opioid Treatment for Experimental Dyspnea

Pain Clinical Trial

— Nefopel  

Official title:

Non Opioid Treatment for Experimental Dyspnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577407
• Other study ID #: P 110103
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2012
• Last updated: December 10, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: October 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this protocol is to test the effects of the non opioid nefopam on experimental dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by dyspnea in healthy subjects.

Description:

Dyspnea and pain share many features. One of them is the counterirritation phenomenon:

defined in pain research as the attenuation of one pain by another pain. Dyspnea induced with inspiratory threshold loading (increased sense of work/effort ) has been shown to attenuate electrical pain as shown through nociceptive flexion reflex inhibition, or thermal pain, as measured with cortical evoked responses (laser evoked potentials-LEP).

The investigators will study whether nefopam modulates the counterirritation of laboratory induced dyspnea in healthy subjects. The effect of nefopam on experimental dyspnea will be measured with a visual analog scale (VAS) and a validated multidimensional dyspnea profile (MDP). The effect of treatment on counterirritation will be measured by recording LEP obtained using a CO2 laser system. The amplitude of the N2-P2 component of the LEP is the main study outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy

• Non-smoking

Exclusion Criteria:

• acute or chronic pain

• antalgic or psychoactive drugs use

• nefopam hypersensibility

• severe allergy

• diabetes

• glaucoma

• prostate adenoma

• seizure disorder or convulsion history

• heart or circulation disease

• pulmonary disease or asthma

• kidney or liver disease

• brain or nerve disease

• lack of adhesion to no antalgic drug, alcohol, coffee and cola within previous experiment day consumption

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea
• Pain

Intervention

Drug:
• Nefopam
Subjects will be infused intravenously with nefopam (20mg/2mL) over a course of 30 minutes in a supine position. There will be a single administration of IV 20 mg nefopam and IV placebo. Each intervention will occur on a separate day.

Locations

Country	Name	City	State
France	Pitié salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of N2-P2 (components of laser evoked potential - tool of pain measurement)amplitude with inspiratory loading induced by intervention	LEP will be recorded before intervention at baseline and after intervention at baseline, during inspiratory loading and recovery. The outcome is the variation of N2-P2 amplitude with inspiratory loading induced by intervention	Change from baseline to 1 hour and half from intervention	No
Secondary	variation of subject rating of breathing discomfort (dyspnea)	repeated measurement on VAS (visual analog scale)	Change from baseline to 1 hour and half from intervention	No
Secondary	variation of N20-P25 amplitude (components of somesthesic evoked potential (SEP) -measurement of sensitivity)	SEP will be recorded before intervention at baseline and after intervention at baseline, during inspiratory loading. This is a methodological control	Change from baseline to 1 hour and half from intervention	No