Nicotine Patch Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01655082
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : December 11, 2012
Information provided by (Responsible Party):
Pierre Fabre Medicament

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.

Condition or disease Intervention/treatment Phase
Smokers Drug: V0116 transdermal patch Drug: Nicotine transdermal patch Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: V0116
One patch per day (during 24 hours) for 21 days
Drug: V0116 transdermal patch
One patch per day (during 24 hours) for 21 days
Active Comparator: Reference
One patch per day (during 24 hours) for 21 days
Drug: Nicotine transdermal patch
One patch per day (during 24 hours) for 21 days

Primary Outcome Measures :
  1. Safety [ Time Frame: up to Day 22 ]
    Evaluation of local safety (number of subjects with skin irritation / number of subjects by score of adhesiveness) and general safety (number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram and clinical laboratory parameters).

Secondary Outcome Measures :
  1. Sensory profile [ Time Frame: Day 22 ]
    Visual Analogic Scales (sensations linked to patch application and removal)

  2. Global assessment by the patient [ Time Frame: Day 22 ]
    Visual Analog Scale Scale and questionnaires

  3. Subject behaviours [ Time Frame: up to Day 22 ]
    nicotine consumption

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01655082

Gières, France
Pierre - Benite, France
Rennes, France
Rueil - Malmaison, France
Sponsors and Collaborators
Pierre Fabre Medicament

Responsible Party: Pierre Fabre Medicament Identifier: NCT01655082     History of Changes
Other Study ID Numbers: V00116 TD 2 02
2011-005911-94 ( EudraCT Number )
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Pierre Fabre Medicament:
Smoking cessation
Tobacco Use Disorder
Central Nervous System Agents

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action