NCT00970450

Brief Summary

  • Paracetamol 1 g;
  • Paracetamol, 1 g and Tropisetron 5 mg;
  • Tropisetron, 5 mg; and
  • Saline. Each volunteer will be allocated to each scenario in a cross-over fashion. Four separate treatment trials, at least two weeks apart, will be performed. Each volunteer will be familiarized with the stimulation procedure prior to participation.
  • Ethical considerations
  • Patient number and timetable
  • Study importance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 20, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

August 20, 2009

Last Update Submit

January 28, 2013

Conditions

Analgesia

Keywords

ParacetamolTropisetronCentral analgesic effectArea of allodyniaSecondary hyperalgesia

Outcome Measures

Primary Outcomes (1)

  • Pain

    all 20 minutes up to 180 minutes after starting the experiment

Study Arms (4)

Paracetamol

EXPERIMENTAL
Drug: Paracetamol

Paracetamol/Tropisetron

EXPERIMENTAL
Drug: ParacetamolDrug: Tropisetron

Saline

PLACEBO COMPARATOR

Proband will receive Saline

Drug: Placebo

Tropisetron

ACTIVE COMPARATOR

Proband will receive Tropisetron alone

Drug: Tropisetron

Interventions

ParacetamolDRUG

Paracetamol 1 g i.v. once

ParacetamolParacetamol/Tropisetron
TropisetronDRUG

Tropisetron 5 mg i.v. once

Paracetamol/TropisetronTropisetron
PlaceboDRUG

Saline

Saline

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers
  • years of age
  • No known medical disorders
  • BMI 18.5 - 39.9 (kg/m2)

You may not qualify if:

  • Known drug allergies (paracetamol, tropisetron)
  • Excessive consumption of tobacco (more than 10 cigarettes a day)
  • Excessive consumption of tea or coffee (more than 5 cups a day)
  • Recreational drug addiction
  • Consumption of any medication on the trial days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Basel

Basel, Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

AgnosiaHyperalgesia

Interventions

AcetaminophenTropisetron

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation Disorders

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Wilhelm Ruppen, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

September 2, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

CH(1)