Study of Nicotine for the Prevention of PONV (NicoPONV)
This study has been terminated.
(Unexpected difficult recruitment. Study drug expired)
Sponsor:
University Hospital, Geneva
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00553709
First received: November 2, 2007
Last updated: September 28, 2009
Last verified: September 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 2, 2007 | ||||||||
| Last Updated Date | September 28, 2009 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Prevention of PONV [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Prevention of PONV [ Time Frame: 48 hours postoperatively ] | ||||||||
| Change History | Complete list of historical versions of study NCT00553709 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction. [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction. [ Time Frame: 48 hours postoperatively ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Nicotine for the Prevention of PONV | ||||||||
| Official Title ICMJE | The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers | ||||||||
| Brief Summary | The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Postoperative Nausea and Vomiting | ||||||||
| Intervention ICMJE | Drug: Nicotine
Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10) |
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| Study Arm (s) |
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| 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 | Terminated | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | August 2009 | ||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00553709 | ||||||||
| Other Study ID Numbers ICMJE | 2006DR3327, APSIC 04-010 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University Hospital, Geneva | ||||||||
| Study Sponsor ICMJE | University Hospital, Geneva | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Geneva | ||||||||
| Verification Date | September 2009 | ||||||||
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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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