|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00487110 |
|
Date of registration:
|
14/06/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol
Tropisétron |
|
Scientific title:
|
|
|
Date of first enrolment:
|
June 2008 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00487110 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Pickering Gisele, MCU-PH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- More than 18 years
- Men or women
- Ear surgery
- Written consent given
Exclusion Criteria:
- Paracetamol hypersensibility
- Tropisetron hypersensibility
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain
|
|
Intervention(s)
|
|
Drug: Tropisetron
|
|
Drug: paracetamol
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary ID(s)
|
|
CHU63-0021
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|