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"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany (VIBRATIONS)

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ClinicalTrials.gov Identifier: NCT01104636
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 24, 2012
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Smoking Cessation
Intervention Drug: Varenicline
Enrollment 1177

Recruitment Details  
Pre-assignment Details A total of 1391 participants were screened and 1177 participants were assigned to the treatment.
Arm/Group Title Varenicline
Hide Arm/Group Description Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
Period Title: Overall Study
Started 1177
Completed 999
Not Completed 178
Reason Not Completed
Lack of Efficacy             43
Lost to Follow-up             24
Withdrawal by Subject             4
Other             43
Study terminated by sponsor             1
Pregnancy             2
Adverse Event             40
Ongoing             21
Arm/Group Title Varenicline
Hide Arm/Group Description Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
Overall Number of Baseline Participants 1173
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1173 participants
49.4  (12.0)
[1]
Measure Description: Demographic data for 4 participants was not available.
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1173 participants
Male 669
Female 503
Unspecified 1
[1]
Measure Description: Demographic data for 4 participants was not available.
1.Primary Outcome
Title Percentage of Participants Who Abstained From Smoking at Week 12
Hide Description The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with ‘no’ answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.
Arm/Group Title Varenicline
Hide Arm/Group Description:
Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 1035
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.1
(68.5 to 73.7)
2.Secondary Outcome
Title Level of Nicotine Dependence Measured by the Fagerstrom Test
Hide Description Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence).
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The all participants’ population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.
Arm/Group Title Varenicline
Hide Arm/Group Description:
Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 1030
Median (Standard Deviation)
Unit of Measure: Scores on a scale
5.30  (2.31)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Varenicline
Hide Arm/Group Description Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%)
Total   7/1177 (0.59%) 
Gastrointestinal disorders   
Nausea * 1  1/1177 (0.08%) 
Injury, poisoning and procedural complications   
Periorbital haematoma * 1  1/1177 (0.08%) 
Road traffic accident * 1  1/1177 (0.08%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  1/1177 (0.08%) 
Nervous system disorders   
Loss of consciousness * 1  1/1177 (0.08%) 
Syncope * 1  1/1177 (0.08%) 
Psychiatric disorders   
Abnormal dreams * 1  1/1177 (0.08%) 
Aggression * 1  2/1177 (0.17%) 
Apathy * 1  1/1177 (0.08%) 
Depression * 1  2/1177 (0.17%) 
Hallucination * 1  1/1177 (0.08%) 
Mood swings * 1  1/1177 (0.08%) 
Suicidal ideation * 1  2/1177 (0.17%) 
Vascular disorders   
Haematoma * 1  1/1177 (0.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Varenicline
Affected / at Risk (%)
Total   40/1177 (3.40%) 
Gastrointestinal disorders   
Nausea * 1  40/1177 (3.40%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v14.0)
It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01104636     History of Changes
Other Study ID Numbers: A3051141
First Submitted: April 14, 2010
First Posted: April 15, 2010
Results First Submitted: January 17, 2012
Results First Posted: February 24, 2012
Last Update Posted: March 2, 2012