Nicotine Patch Safety Study

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Medicament Identifier:
First received: July 30, 2012
Last updated: December 10, 2012
Last verified: December 2012
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 Intervention Phase
Drug: V0116 transdermal patch
Drug: Nicotine transdermal patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Safety [ Time Frame: up to Day 22 ] [ Designated as safety issue: Yes ]
    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:
  • Sensory profile [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Visual Analogic Scales (sensations linked to patch application and removal)

  • Global assessment by the patient [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Visual Analog Scale Scale and questionnaires

  • Subject behaviours [ Time Frame: up to Day 22 ] [ Designated as safety issue: No ]
    nicotine consumption

Enrollment: 160
Study Start Date: August 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01655082

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

No publications provided

Responsible Party: Pierre Fabre Medicament Identifier: NCT01655082     History of Changes
Other Study ID Numbers: V00116 TD 2 02  2011-005911-94 
Study First Received: July 30, 2012
Last Updated: December 10, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Comité de Protection des Personnes
France: Conseil National de l'Ordre des Médecins

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

Additional relevant MeSH terms:
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 07, 2016