A RANDOMIZED, MULTICENTRE, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY OF VARENICLINE IN CESSATION OF ORAL TOBACCO USE

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-000546-31-SE
• Date of registration: 27/05/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ
• Public title: A RANDOMIZED, MULTICENTRE, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY OF VARENICLINE IN CESSATION OF ORAL TOBACCO USE
• Scientific title: A RANDOMIZED, MULTICENTRE, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY OF VARENICLINE IN CESSATION OF ORAL TOBACCO USE
• Date of first enrolment: 16/07/2008
• Target sample size: 432
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000546-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Have evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of and has understood all pertinent aspects of the study.
2. Male or female daily smokeless tobacco users aged 18 years and older, who are
motivated to stop use of all tobacco products.
3. Subjects must be daily users of nicotine containing smokeless tobacco and using
smokeless tobacco on at least 8 occasions per day averaged over a week.
4. Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.
5. If female, be not of childbearing potential (ie, surgically sterile or postmenopausal for at least one year), or be non-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner) for a least one month prior to the screening visit, and for the duration of the study period.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects with any of the following will not be included in the study:
1. Subjects using nicotine containing products (including smoking tobacco) other than
smokeless tobacco for 3 months prior to screening.
2. Subjects with exhaled Carbon Monoxide (CO) =10 ppm at baseline.
3. Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
4. Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.
5. Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months.
6. Subjects receiving concomitant treatment with another investigational drug within 30 days of the study baseline visit or with plans to take another investigational drug within 30 days of study completion (after Week 26 visit).
7. Subjects with an uncontrolled, unstable clinically significant medical condition (eg, renal, hepatic, endocrine, respiratory, cardiovascular, haematologic, immunologic,
cerebrovascular disease, diabetic or have malignancy), which, in the opinion of the
investigator, may interfere with the interpretation of safety or efficacy evaluations.
8. The contraindication of varenicline is hypersensitivity to the active substance or to any of the excipients.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cessation of oral smokeless tobacco use in current non-smokers.
MedDRA version: 9.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy

Intervention(s)

Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Film-coated tablet
CAS Number: 249296-44-4
Current Sponsor code: Varenicline Tartrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Film-coated tablet
CAS Number: 249296-44-4
Current Sponsor code: Varenicline Tartrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To compare the efficacy of varenicline to placebo for cessation of use of smokeless tobacco assessed using the 4 week Continuous Quit Rate (CQR) at the end of treatment.

Primary end point(s): The 4-week Continuous Quit Rate (CQR) from smokeless tobacco use assessed for the 4 weeks prior to the end of treatment (Week 9 through to 12). This will be assessed using the nicotine use inventory (NUI) and confirmed by salivary cotinine at the weekly visits from Week 9 through to 12.

Secondary Objective: To compare varenicline with placebo for the Continuous Abstinence (CA) of smokeless
tobacco from Weeks 9 through to 26.
• Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of treatment (Week 12).
• Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of study (Week 26).
• Compare varenicline with placebo for the long term quit rate (LTQR) of smokeless
tobacco from Weeks 9 through to 26.
• To assess the safety and tolerability of varenicline with placebo, for 12 weeks of
treatment in users of smokeless tobacco.

Secondary ID(s)

A3051104