Nicotine Patch Safety Study

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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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

V0116
Experimental group
Description:
One patch per day (during 24 hours) for 21 days
Treatment:
Drug: V0116 transdermal patch
Reference
Active Comparator group
Description:
One patch per day (during 24 hours) for 21 days
Treatment:
Drug: Nicotine transdermal patch

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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