Nicotine Patch Safety Study

Smokers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655082
• Other study ID #: V00116 TD 2 02
• Secondary ID: 2011-005911-94
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2012
• Last updated: December 10, 2012
• Start date: August 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Comité de Protection des PersonnesFrance: Conseil National de l'Ordre des Médecins
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Smokers

Intervention

Drug:
• V0116 transdermal patch
One patch per day (during 24 hours) for 21 days
• Nicotine transdermal patch
One patch per day (during 24 hours) for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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).	up to Day 22	Yes
Secondary	Sensory profile	Visual Analogic Scales (sensations linked to patch application and removal)	Day 22	No
Secondary	Global assessment by the patient	Visual Analog Scale Scale and questionnaires	Day 22	No
Secondary	Subject behaviours	nicotine consumption	up to Day 22	No