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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00682461 |
This study is to evaluate the oral tolerability of a nicotine prototype
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteer Smokers |
Drug: Nicotine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Open Label Study to Evaluate the Oral Tolerability of a Nicotine Prototype |
Estimated Enrollment: | 200 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Smoking status
Exclusion Criteria:
Nicotine use
Oral condition
Allergy/Intolerance
Clinical Study/Experimental medication
Substance abuse
Personnel
United States, New Jersey | |
GSK Investigatin Site | Recruiting |
Paramus, New Jersey, United States, 07652 | |
Contact: GSK Clinical Trials Call Center 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | S2110367 |
Study First Received: | May 20, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00682461 |
Health Authority: | United States: Food and Drug Administration |
Nicotine Tolerability NRT |
Nicotine polacrilex Nicotine Healthy |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |