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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT01675986 |
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Date of registration:
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07/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
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Scientific title:
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Date of first enrolment:
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November 2012 |
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Target sample size:
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306 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01675986 |
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Study type:
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Interventional |
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Study design:
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N/A
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Bertrand DEBAENE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Poitiers University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged from 18 to 75 years
- Patient schedules for insertion of long-lasting intravenous device
Exclusion Criteria:
- History of previous insertion of long-lasting intravenous device or central
intravenous catheter
- long term treatment of gabapentin or pregabalin
- Hypersensitivity to pregabalin or any of the excipients
- Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients,
another derivative of piperazine, aminophylline or ethylene diamine.
- Patient at risk of glaucoma e
- Patient at risk for urinary retention
- Patient severe respiratory failure
- Patient at the general condition not too corrupted (ASA IV)
- Renal failure with creatinin clearance < 30 ml / min
- Patient not affiliated to Social Security
- Pregnant or lactating
- Patients in emergency situations
- Inpatient without consent
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Feeling Anxious
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Intervention(s)
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Drug: Lactose
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Drug: hydroxyzine
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Drug: Pregabalin
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Primary Outcome(s)
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Efficacy treatment
[Time Frame: anxiety score VAS: 0 to 100]
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Secondary Outcome(s)
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Efficacy of pregabaldin
[Time Frame: anxiety score VAS:0 to 100]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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