Clinical Trial Results:
Efficacy of smoking cessation with varenicline for e-cigarettes users: a randomized controlled trial (VAREVAPE)
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Summary
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EudraCT number |
2016-000339-42 |
Trial protocol |
IT |
Global end of trial date |
30 Sep 2020
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Results information
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Results version number |
v2(current) |
This version publication date |
07 Jan 2023
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First version publication date |
05 Apr 2022
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Other versions |
v1 |
Version creation reason |
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Summary report(s) |
RESULTS SU PREPRINT |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
W1206810 Pfizer GRAND
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer
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Sponsor organisation address |
NEW YORK, NEW YORK, United States,
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Public contact |
NA, Pfizer, 1 800-438-1985, pfizercentreone@pfizer.com
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Scientific contact |
NA, NA, 1 800-438-1985, pfizercentreone@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Aug 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Sep 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Sep 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This study intends to evaluate the efficacy and safety of varenicline 1 mg BID in the cessation of smoking electronic cigarette (single users) or combined use, electronic and classical cigarette (dual users).
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Protection of trial subjects |
Vital signs monitor
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Apr 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 280
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Worldwide total number of subjects |
280
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EEA total number of subjects |
280
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
280
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Made by social media | |||||||||
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Pre-assignment
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Screening details |
At screening visit, participants were seen in a screening visit, during which informed consent was be obtained prior to any study procedures. Physical examination, blood pressure, pulse rate cardiological visit and electrocardiogram were done. A serum pregnancy test was completed for all females at the screening. | |||||||||
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Period 1
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Period 1 title |
All time (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Varenicline | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Varenicline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Buccal use
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Dosage and administration details |
0.5 mg
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Buccal use
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Dosage and administration details |
0.5 mg
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End points reporting groups
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Reporting group title |
Varenicline
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
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End point title |
vaping cessation | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 weeks
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Statistical analysis title |
sap | |||||||||
Statistical analysis description |
Methods of Analysis
Baseline and summary statistics will be calculated and reported for each treatment
group. At baseline, differences between experimental and control groups will be
evaluated by means of 1-way analysis of variance (ANOVA) for normally distributed
continuous variables and by Mann-Whitney U-test for not normally distributed
continuous variables; the χ2 test of independence will be used for categorical
variables. Secondary endpoints will be analyzed using procedures simila
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Comparison groups |
Varenicline v Placebo
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Number of subjects included in analysis |
280
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
3 months
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
1
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Not revealed during the study |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
