Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol (Tropisétron)
This study has been completed.
Sponsor:
University Hospital, Clermont-Ferrand
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 14, 2007 | ||||
| Last Updated Date | March 26, 2010 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups | ||||
| Change History | Complete list of historical versions of study NCT00487110 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| 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 ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00487110 | ||||
| Other Study ID Numbers ICMJE | CHU63-0021 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dr Pickering Gisele, CHU Clermont-Ferrand | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Clermont-Ferrand | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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