CompletedInterventionalPhase 2Phase 3Updated Jan 12, 2017
Nicotine Patch Safety Study | NCT01655082 | Trialant
CompletedInterventionalPhase 2Updated Dec 11, 2012
Nicotine Patch Safety Study
ClinicalTrials.gov ID
NCT01655082
Lead Sponsor
Pierre Fabre MedicamentINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
160Actual
Last Update Posted
Dec 11, 2012Estimated
Start Date
Aug 2012
Primary Completion Date
Oct 2012Actual
Completion Date
Oct 2012Actual
Brief Summary
The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.
Smokers
V0116 transdermal patch
Nicotine transdermal patch
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged more than 18 years
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:
Any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters
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)