Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
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ClinicalTrials.gov Identifier: NCT01675986 |
Recruitment Status
:
Completed
First Posted
: August 30, 2012
Last Update Posted
: October 11, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | February 7, 2012 | |||
First Posted Date ICMJE | August 30, 2012 | |||
Last Update Posted Date | October 11, 2016 | |||
Study Start Date ICMJE | Not Provided | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Efficacy treatment anxiety score VAS: 0 to 100
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01675986 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Efficacy of pregabaldin anxiety score VAS:0 to 100
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies. Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable. Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Not Provided | |||
Condition ICMJE | Feeling Anxious | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
306 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01675986 | |||
Other Study ID Numbers ICMJE | GABAPAC | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Poitiers University Hospital | |||
Study Sponsor ICMJE | Poitiers University Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Poitiers University Hospital | |||
Verification Date | October 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |