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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00317213 |
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Date of registration:
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20/04/2006 |
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Primary sponsor: |
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Public title:
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Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
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Scientific title:
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Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00317213 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Zeev T. Handzel, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kaplan Medical Center |
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Name:
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Avner Shenfeld, Ph.D, |
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Address:
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Telephone:
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Email:
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Affiliation:
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Modus Biological Membranes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Smokers of at least 1 year duration
- Smoking at least 10 cigarettes/day
- Having failed at least one previous smoking cessation effort.
- Without a major cardio-vascular or metabolic disease or condition.
Exclusion Criteria:
- An uncontrolled major cardiovascular, metabolic, or other condition condition.
- Need for surgery during the period of participation in the trial.
- Any treatment for smoking cessation during the 2 months preceding enrollment in the
present trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Smoking
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Intervention(s)
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Drug: LIBERTAL- a phospholipid mixture
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Primary Outcome(s)
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Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
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Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
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Secondary Outcome(s)
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Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
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Secondary ID(s)
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LIB-05-2001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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