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Nicotine Patch Safety Study

This study is currently recruiting participants.
Verified August 2012 by Pierre Fabre Medicament
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01655082
First received: July 30, 2012
Last updated: August 27, 2012
Last verified: August 2012
History of Changes

July 30, 2012
August 27, 2012
August 2012
November 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01655082 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
Nicotine Patch Safety Study
 

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.
 
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smokers
  • Drug: V0116 transdermal patch
    One patch per day (during 24 hours) for 21 days
  • Drug: Nicotine transdermal patch
    One patch per day (during 24 hours) for 21 days
  • Experimental: V0116
    One patch per day (during 24 hours) for 21 days
    Intervention: Drug: V0116 transdermal patch
  • Active Comparator: Reference
    One patch per day (during 24 hours) for 21 days
    Intervention: Drug: Nicotine transdermal patch
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
November 2012
November 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Pierre Fabre Médicament contact_essais_cliniques@pierre-fabre.com
France
 
NCT01655082
V00116 TD 2 02, 2011-005911-94
 
Pierre Fabre Medicament
Pierre Fabre Medicament
 
 
Pierre Fabre Medicament
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP