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NCT00487110 Clinical Trial

Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

Pain Clinical Trial

— Tropisétron  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00487110
Other study ID # CHU63-0021
Secondary ID
Status Completed
Phase Phase 4
First received June 14, 2007
Last updated March 26, 2010
Start date June 2008
Est. completion date June 2009

Study information
Verified date March 2010
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- More than 18 years

- Men or women

- Ear surgery

- Written consent given

Exclusion Criteria:

- Paracetamol hypersensibility

- Tropisetron hypersensibility

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHU Clermont-Ferrand

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups at 30 min, 1h, 2h, 3h Yes
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