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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00487110
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : March 29, 2010
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Tropisetron Drug: paracetamol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

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


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487110


Locations
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France
CHU
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Pickering Gisele, MCU-PH

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Responsible Party: Dr Pickering Gisele, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00487110    
Other Study ID Numbers: CHU63-0021
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010
Keywords provided by University Hospital, Clermont-Ferrand:
Pain
serotonin
interaction
Patients with postsurgical pain, after ear surgery
Additional relevant MeSH terms:
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Acetaminophen
Tropisetron
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action