Nicotine Patch Safety Study

Pierre Fabre

Status and phase

Completed

Phase 2

Conditions

Smokers

Treatments

Drug: V0116 transdermal patch

Drug: Nicotine transdermal patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01655082

V00116 TD 2 02

2011-005911-94 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)