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Non Opioid Treatment for Experimental Dyspnea (Nefopel)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01577407
First received: February 23, 2012
Last updated: December 10, 2012
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Dyspnea
Pain
 Drug: Nefopam
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non Opioid Treatment for Experimental Dyspnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • variation of subject rating of breathing discomfort (dyspnea) [ Time Frame: Change from baseline to 1 hour and half from intervention ] [ Designated as safety issue: No ]
    repeated measurement on VAS (visual analog scale)

  • 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 ] [ Designated as safety issue: No ]
    SEP will be recorded before intervention at baseline and after intervention at baseline, during inspiratory loading. This is a methodological control


Enrollment: 15
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: acupan
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 Name: acupan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577407

Locations
France
Pitié salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Capucine Morelot, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01577407     History of Changes
Other Study ID Numbers: P 110103
Study First Received: February 23, 2012
Last Updated: December 10, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dyspnea
Pain

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Nefopam
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013