Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2012-08-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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V0116
One patch per day (during 24 hours) for 21 days
V0116 transdermal patch
One patch per day (during 24 hours) for 21 days
Reference
One patch per day (during 24 hours) for 21 days
Nicotine transdermal patch
One patch per day (during 24 hours) for 21 days
Interventions
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V0116 transdermal patch
One patch per day (during 24 hours) for 21 days
Nicotine transdermal patch
One patch per day (during 24 hours) for 21 days
Eligibility Criteria
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Inclusion Criteria
* Regular smoker motivated to stop tobacco consumption
* Current smoker of \> or = 20 cigarettes/day and \< or = 25 cigarettes/day or Fagerström score \> or = 5 (for smokers between 10 to 20 cigarettes/day)
Exclusion Criteria
* Current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer
* History of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke
* Clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Locations
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Gières, , France
Pierre-Bénite, , France
Rennes, , France
Rueil-Malmaison, , France
Countries
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Other Identifiers
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2011-005911-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V00116 TD 2 02
Identifier Type: -
Identifier Source: org_study_id