CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 432 enrolled
Drug / intervention
Varenicline Tartrate +1 moredrug
Likely dose
Varenicline Tartrate 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00717093
NCT00717093Phase 4Completed
CompareCT.gov

A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

Pfizer·interventional·Posted Jul 16, 2008·Updated Jul 23, 2015

In Brief

A Phase 4 clinical trial evaluating Varenicline Tartrate and Placebo for Tobacco Use Cessation. Completed, enrolled 432 participants across 16 sites in 2 countries.

Detailed Summary

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Cessation
CountriesNorway, Sweden
Collaborators--

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.0 years ago

Interventions

Varenicline Tartratedrug

Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Placebodrug

Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.