NCT01655082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

July 30, 2012

Last Update Submit

December 10, 2012

Conditions

Smokers

Keywords

Smoking cessationNicotineTobacco Use DisorderCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Sensory profile

    Day 22

  • Global assessment by the patient

    Day 22

  • Subject behaviours

    up to Day 22

Study Arms (2)

V0116

EXPERIMENTAL

One patch per day (during 24 hours) for 21 days

Drug: V0116 transdermal patch

Reference

ACTIVE COMPARATOR

One patch per day (during 24 hours) for 21 days

Drug: Nicotine transdermal patch

Interventions

V0116 transdermal patchDRUG

One patch per day (during 24 hours) for 21 days

V0116
Nicotine transdermal patchDRUG

One patch per day (during 24 hours) for 21 days

Reference

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Gières, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Rennes, France

Location

Unknown Facility

Rueil-Malmaison, France

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 1, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations

FR(4)