NCT03122665

Brief Summary

Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

October 26, 2016

Last Update Submit

June 16, 2020

Conditions

Hypothermia

Keywords

NefopamPharmacokineticsShivering,ThermoregulationAnesthesia

Outcome Measures

Primary Outcomes (4)

  • V1

    Volume of distribution 1

    three hours of infusion

  • V2

    Volume of distribution2

    three hours of infusion

  • CLel

    Clearance

    three hours of infusion

  • CLdist

    Clearance distribution

    three hours of infusion

Study Arms (2)

Nefopam low dose

ACTIVE COMPARATOR

Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours.

Drug: Nefopam Low dose

Nefopam high dose

ACTIVE COMPARATOR

Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.

Drug: Nefopam High dose

Interventions

Nefopam Low doseDRUG

Continuous intravenous infusion at 0.5 mg/ml for three hours.

Also known as: Low
Nefopam low dose
Nefopam High doseDRUG

Continuous intravenous infusion at 1.0 mg/ml for three hours.

Also known as: High
Nefopam high dose

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal healthy volunteers ages 18-40

You may not qualify if:

  • history of alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University of Bern

Bern, Freiburgstrasses, 3010, Switzerland

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Nefopam

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blinded drug containers.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Volunteers given two doses of nefopam in a crossover protocol.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

April 21, 2017

Study Start

August 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)