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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Keywords provided by University Hospital, Clermont-Ferrand:
Patients with postsurgical pain, after ear surgery

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Antipyretics processed this record on May 25, 2017