Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol - Full Text View

Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol (Tropisétron)

This study has been completed.

First Received on June 14, 2007. Last Updated on March 26, 2010 History of Changes

Sponsor:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00487110

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Tropisetron Drug: paracetamol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Serotonin Tropisetron Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups [ Time Frame: at 30 min, 1h, 2h, 3h ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Study Completion Date:	June 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

The study is a comparison of the analgesic action of paracetamol versus tropisetron + paracetamol in 30 patients who had surgery of the ear. The evaluation criteria will be the score on the visual analogue scale for pain evaluation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Paracetamol hypersensibility
Tropisetron hypersensibility

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487110

Locations

France
CHU
Clermont-Ferrand, France, 63000

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:

Pickering Gisele, MCU-PH

More Information

No publications provided

Responsible Party:	Dr Pickering Gisele, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00487110 History of Changes
Other Study ID Numbers:	CHU63-0021
Study First Received:	June 14, 2007
Last Updated:	March 26, 2010
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Pain
serotonin
interaction
Patients with postsurgical pain, after ear surgery

Additional relevant MeSH terms:

Acetaminophen
Tropisetron
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Central Nervous System Agents
Therapeutic Uses
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012