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

This study has been completed.
Information provided by:
University Hospital, Clermont-Ferrand Identifier:
First received: June 14, 2007
Last updated: March 26, 2010
Last verified: March 2010
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
Drug: Tropisetron
Drug: paracetamol
Phase 4

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:

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:
    Drug: Tropisetron
    a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol
    Drug: paracetamol
    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.

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Paracetamol hypersensibility
  • Tropisetron hypersensibility
  Contacts and Locations
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Please refer to this study by its identifier: NCT00487110

Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Pickering Gisele, MCU-PH
  More Information

Responsible Party: Dr Pickering Gisele, CHU Clermont-Ferrand 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:
Patients with postsurgical pain, after ear surgery

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Autonomic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Serotonin Agents
Serotonin Antagonists processed this record on May 26, 2016