Non Opioid Treatment for Experimental Dyspnea
Nefopel
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 11, 2012
October 1, 2011
8 months
February 23, 2012
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
variation of subject rating of breathing discomfort (dyspnea)
Change from baseline to 1 hour and half from intervention
variation of N20-P25 amplitude (components of somesthesic evoked potential (SEP) -measurement of sensitivity)
Change from baseline to 1 hour and half from intervention
Study Arms (2)
Nefopam
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy
- Non-smoking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pitié salpetriere Hospital
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Capucine Morelot, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
April 13, 2012
Study Start
September 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
December 11, 2012
Record last verified: 2011-10