Non Opioid Treatment for Experimental Dyspnea (Nefopel)

December 10, 2012 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Pitie Salpetriere Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
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.
Other Names:
  • acupan
EXPERIMENTAL: Nefopam
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.
Other Names:
  • acupan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation of N2-P2 (components of laser evoked potential - tool of pain measurement)amplitude with inspiratory loading induced by intervention
Time Frame: Change from baseline to 1 hour and half from 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation of subject rating of breathing discomfort (dyspnea)
Time Frame: Change from baseline to 1 hour and half from intervention
repeated measurement on VAS (visual analog scale)
Change from baseline to 1 hour and half from intervention
variation of N20-P25 amplitude (components of somesthesic evoked potential (SEP) -measurement of sensitivity)
Time Frame: Change from baseline to 1 hour and half from intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Capucine Morelot, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (ESTIMATE)

April 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 110103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Nefopam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe