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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00487110
First received: June 14, 2007
Last updated: March 26, 2010
Last verified: March 2010
  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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics
Analgesics, Non-Narcotic
Antiemetics
Antipyretics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014