Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00414752 |
Recruitment Status
:
Completed
First Posted
: December 22, 2006
Last Update Posted
: June 22, 2007
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Sponsor:
Novartis
Information provided by:
Novartis
Tracking Information | ||||
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First Submitted Date ICMJE | December 21, 2006 | |||
First Posted Date ICMJE | December 22, 2006 | |||
Last Update Posted Date | June 22, 2007 | |||
Study Start Date ICMJE | September 2006 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00414752 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking | |||
Official Title ICMJE | A Randomized, Double Blind, Multiple Dose, Cross-Over, Placebo- and Active-Controlled Proof of Concept Study to Explore the Effects of AFQ056 and Nicotine (Active Comparator) on Craving and Withdrawal During Voluntary Smoking Abstinence in Healthy Smokers | |||
Brief Summary | The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Smoking Abstinence | |||
Intervention ICMJE | Drug: AFQ065 | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
36 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00414752 | |||
Other Study ID Numbers ICMJE | CAFQ056A2109 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Novartis | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | June 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |