Nicotine Patch Safety Study

Phase 2

Completed

• Conditions: Smokers
• Interventions: Drug: V0116 transdermal patch; Drug: Nicotine transdermal patch

• Registration Number: NCT01655082
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-07-31
• Study Start: 2012-08
• Study First Posted: 2012-08-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V0116	V0116 transdermal patch	One patch per day (during 24 hours) for 21 days
Reference	Nicotine transdermal patch	One patch per day (during 24 hours) for 21 days

Primary Outcome Measures

Name	Time	Method
Safety	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

Name	Time	Method
Sensory profile	Day 22	Visual Analogic Scales (sensations linked to patch application and removal)
Global assessment by the patient	Day 22	Visual Analog Scale Scale and questionnaires
Subject behaviours	up to Day 22	nicotine consumption