Tropisétron: Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Completed
• CT.gov ID: NCT00487110
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Outcome Measures

Primary Outcome Measures

1. Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups [at 30 min, 1h, 2h, 3h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	CHU	Clermont-Ferrand		France	63000

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Pickering Gisele, MCU-PH,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00487110
• Other Study ID Numbers: CHU63-0021
• First Posted: Jun 15, 2007
• Last Update Posted: Mar 29, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Pain; serotonin; interaction; Patients with postsurgical pain, after ear surgery
• Additional relevant MeSH terms: Acetaminophen; Tropisetron

Study Results

No Results Posted as of Mar 29, 2010