SmokersPhase 2NCT01655082
Nicotine Patch Safety Study
A Phase 2 study testing V0116 transdermal patch and Nicotine transdermal patch in people with Smokers, run by Pierre Fabre Medicament at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smokers
- What is being tested?
- V0116 transdermal patch and Nicotine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesFrance
- Study dates
- Aug 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Study site
Gières
Study site
Pierre-Bénite
Study site
Rennes
Study site
Rueil-Malmaison
About this 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.
- Conditions
- Smokers
- Being tested
- V0116 transdermal patch, Nicotine transdermal patch
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0116 transdermal patchDrug
One patch per day (during 24 hours) for 21 days
Nicotine transdermal patchDrug
One patch per day (during 24 hours) for 21 days
| Study group | Role | What they receive |
|---|---|---|
| V0116 | Experimental | One patch per day (during 24 hours) for 21 days Receives: Drug: V0116 transdermal patch |
| Reference | Active comparator | One patch per day (during 24 hours) for 21 days Receives: Drug: Nicotine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to Day 22
Secondary outcomes (3)
Sensory profile
Visual Analogic Scales (sensations linked to patch application and removal)
Measured: Day 22
Global assessment by the patient
Visual Analog Scale Scale and questionnaires
Measured: Day 22
Subject behaviours
nicotine consumption
Measured: up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655082
- Sponsor's protocol ID
- V00116 TD 2 02
- Other IDs
- 2011-005911-94
- Status last verified
- Dec 2012
- First submitted
- 30 Jul 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Patch Safety Study
- ClinicalTrials.gov ID
- NCT01655082
- Acronym / sponsor ID
- V00116 TD 2 02
- Conditions
- Smokers
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V0116 | Experimental | Drug: V0116 transdermal patchOne patch per day (during 24 hours) for 21 days |
| Reference | Active comparator | Drug: Nicotine transdermal patchOne patch per day (during 24 hours) for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V0116 transdermal patchOne patch per day (during 24 hours) for 21 days | Drug | V0116 |
| Nicotine transdermal patchOne patch per day (during 24 hours) for 21 days | Drug | Reference |
Primary outcome
Safety
Time frame: 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).
3 secondary outcomes
Sensory profile
Time frame: Day 22
Global assessment by the patient
Time frame: Day 22
Subject behaviours
Time frame: up to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V0116 transdermal patch and Nicotine transdermal patch in people with Smokers, run by Pierre Fabre Medicament at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: up to Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.