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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00750048 |
Date of registration:
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09/09/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers
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Scientific title:
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Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers |
Date of first enrolment:
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September 2008 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00750048 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Pickering Gisele, Dr |
Address:
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Telephone:
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Email:
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Affiliation:
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CIC-CPC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy men
- between 18 and 40 years old
- written consent given
Exclusion Criteria:
- Naloxone or paracetamol hypersensibility
- Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
- Concomitant medication
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Drug: Naloxone and paracetamol
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Primary Outcome(s)
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Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.
[Time Frame: before and after administration of Naloxone]
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Secondary Outcome(s)
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Follow up of pain's evaluation using analogical visual scale. Follow up of pain's evaluation using analogical visual scale
[Time Frame: following the pain's evaluation]
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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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