NCT00487110

Brief Summary

A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jun 2008

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

June 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 29, 2010

Status Verified

March 1, 2010

Enrollment Period

6 months

First QC Date

June 14, 2007

Last Update Submit

March 26, 2010

Conditions

Pain

Keywords

PainserotonininteractionPatients with postsurgical pain, after ear surgery

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups

    at 30 min, 1h, 2h, 3h

Interventions

TropisetronDRUG

a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol

paracetamolDRUG

a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 18 years
  • Men or women
  • Ear surgery
  • Written consent given

You may not qualify if:

  • Paracetamol hypersensibility
  • Tropisetron hypersensibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain

Interventions

TropisetronAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pickering Gisele, MCU-PH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 15, 2007

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

March 29, 2010

Record last verified: 2010-03

Locations

FR(1)