Study safety and effectiveness of a reduce to quit approach using varenicline versus placebo

• Register: EUCTR
• Last refreshed on: 28 October 2013
• Main ID: EUCTR2010-021788-33-DE
• Date of registration: 26/05/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017 US
• Public title: Study safety and effectiveness of a reduce to quit approach using varenicline versus placebo
• Scientific title: A PHASE 4, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VARENICLINE COMPARED TO PLACEBO FOR SMOKING CESSATION THROUGH REDUCTION - Reduce to Quit
• Date of first enrolment: 27/07/2011
• Target sample size: 1404
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021788-33
• 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 Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Canada, Czech Republic, Egypt, Germany, Japan, Mexico, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
3. Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) >10 ppm at screening.
4. Subjects with history of lifetime or current mild to moderate (investigator opinion) major depressive disorder (MDD), depression, depressed mood, anxiety, and anxiety disorders (including general anxiety disorder (GAD), obsessive compulsive disorder (OCD) and phobias such as agoraphobia and social phobia) may be included if their condition is stable. Stability is defined as:
•If on medication, on the same dose for the past 6 months;
•No hospitalizations for exacerbations in the past 6 months.
5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
6. Females who are not of childbearing potential (ie, who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and who meet all of the following criteria:
• Are instructed and agree to avoid pregnancy through 30 days after the last dose of study medication;
• Have a negative pregnancy test (beta-hCG) at Screening and Baseline and agree to use at least one of the birth control methods listed below:
• An oral contraceptive agent, an intrauterine device (IUD), an implantable contraception (eg, Norplant), or an injectable contraceptive (eg, Depo Provera) for at least 1 month prior to entering the study and will continue it's use through at least 30 days after the last dose of study medication; or:
• A double barrier method of contraception, (ie condom plus spermicide in combination with a female condom, diaphragm, cervical cap, or intrauterine device) or sexual abstinence prior to entering into the study and for at least least 30 days after the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1334
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion criteria:
1. Subjects with a history of a suicide attempt or any suicidal behavior in the past two years as assessed using the C-SSRS and/or the SBQ- R.
• History of suicidal ideation with intent/plan in the past 6 months (“yes” to Questions 4 and/or 5 on the C-SSRS) or at the screening or baseline visit.
2. Subjects with lifetime or current severe major depressive disorder (MDD), depression, depressed mood, anxiety, or anxiety disorder (including generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD), and phobias such as agoraphobia and social phobia).
3. Subjects with unstable mild to moderate major depressive disorder (MDD), depression, depressed mood, anxiety, or anxiety disorder (including generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD),and phobias) such as agoraphobia and social phobia
4. Subjects with a lifetime diagnosis or treatment for psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
5. Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
6. Subjects with a positive urine drug screen (at screening or baseline) for drugs of abuse/potential abuse not prescribed for the treatment of a medical condition.
7. Subjects previously enrolled in a study that included varenicline (CP-526,555) or subject who have previously taken Chantix®/ Champix®. Subjects who have taken a very limited number of prescription doses may be considered pending discussion with the study clinician.
8. Subjects who have participated in other studies within 30 days prior to the screening visit of this study or any time during this study.
9. Subject with an SGOT (AST) or SGPT (ALT) greater than 3 times the upper limit of normal (ULN) or total bilirubin greater than 2 times the ULN at screening.
10. Subjects having clinically significant medical disorders or clinically significant laboratory test abnormalities as determined by the Principal Investigator.
11. Subjects with severe chronic obstructive pulmonary disease (COPD) defined as any subject who fulfills any of the following criteria:
• History of repeated exacerbations of COPD (greater than or equal to 3 in 3 years).
• Requires systemic corticosteroid maintenance (eg, oral prednisolone) for management of chronic symptoms.
• Is maintained on oxygen therapy for management of chronic symptoms.
12. Subjects with a recent (<5 years) history of cancer. Subjects with completely excised carcinoma in situ of the cervix or completely excised melanomas <5 years prior to screening may be considered pending discussion with the study clinician. Subjects with a remote (>5 years) history of cancer may be considered pending discussion with the study clinician.
• Subjects with cured basal cell or squamous cell carcinoma of the skin are allowed.
13. Subjects with evidence or history of clinically significant allergic reactions to drugs (eg, anaphylaxis or Stevens-Johnson syndrome).
14. Subjects with a clinically significant ECG at the screening visit (as determined by the Principal Investigator or medically appropriate designee).
15. Subjects with clinically significant cardiovascular disease in the past 2 months.
Examples of clinically significant cardiovascular disease include:
• Myocardial infarction;
• Coronary artery bypass graft (CABG);
• Percutaneous transluminal coronary angioplasty (PTCA);
• Severe or unstable angina;
• Serious arrhythmia;
•

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

Health Condition(s) or Problem(s) studied

Smoking Cessation
MedDRA version: 14.1 Level: LLT Classification code 10008374 Term: Cessation of smoking System Organ Class: 100000004869

Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

Intervention(s)

Trade Name: CHAMPIX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VARENICLINE TARTRATE
CAS Number: 375815-87-5
Other descriptive name: 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

Primary Outcome(s)

Secondary Objective: Secondary objectives are the comparison of varenicline to placebo during the last four weeks
of treatment and through the longer term follow-up phase to Week 52.

Primary end point(s): CO confirmed Continuous Abstinence (CA) during the last 10 weeks of treatment weeks 15-24.

Main Objective: The primary objective is to compare the efficacy of varenicline to placebo for smoking cessation during the last 10 weeks of treatment in subjects who are not willing/able to make an abrupt quit attempt but are willing to reduce their smoking with the ultimate goal of quitting.

Timepoint(s) of evaluation of this end point: CO confirmed CA during the last 10 weeks of treatment weeks 15-24

Secondary Outcome(s)

Secondary end point(s): ?CO confirmed Continuous Abstinence (CA) Weeks 21-24;
?CO confirmed Continuous Abstinence (CA) Weeks 21-52.
Other secondary endpoints:
?7 day point prevalence of smoking cessation at Weeks 12, 24, and 52;
?4 week point prevalence of smoking cessation at Week 52.

Timepoint(s) of evaluation of this end point: Key secondary: CO confirmed CA weeks 21-24 and also weeks 21-52. Other: 7 day point prevalence of smoking cessation at Weeks 12,24 and 52; 4 week point prevalence of smoking cessation at Week 52

Secondary ID(s)

A3051075

2010-021788-33-CZ

Source(s) of Monetary Support

Pfizer Inc