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ISRCTN
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ISRCTN43027384
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ClinicalTrials.gov identifier
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Public title
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The evaluation of the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine; as compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine).
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Lay summary
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Ethics approval
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Approved by the West Virginia University's Institutional Review Board in 1997, reference number: HS13781
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Study design
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Multicenter (n=4), double-blind, randomized, parallel group, repeat dose study
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Cigarette smoking
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Participants - inclusion criteria
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1. Males or females motivated to quit smoking between the ages of 18 and 70 years
2. Smoked at least 20 cigarettes a day for three years or more (smoking confirmed via expired CO level >10 ppm).
All subjects had normal blood pressure and heart rate, weighed more than 100 pounds and typically no more than 130% of their ideal body weight, and expressed willingness to quit smoking on the specified target quit date (TQD). They were not currently using smokeless tobacco or other nicotine products. A detailed medical history, routine physical examination, laboratory tests and electrocardiogram (ECG) confirmed that subjects were in general good health. All women had a negative pregnancy test and agreed to use a medically accurate contraceptive method.
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Participants - exclusion criteria
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Participants were excluded if they had a history of significant hepatic, renal, endocrine, cardiac, psychiatric, gastrointestinal, pulmonary, or metabolic disorder including hyperthyroidism, pheochromocytoma, diabetes, severe coronary insufficiency, recent myocardial infarction (within 90 days), glaucoma, cerebrovascular disease, stroke, chronic renal failure, prostatic hypertrophy, prostatic disease, bladder neck obstruction, urine retention, urethral stricture, a history of atopic or eczematous dermatitis, psoriasis, or altered skin condition at patch application site.
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Anticipated start date
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01/01/1997
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Anticipated end date
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31/12/1998
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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375
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Interventions
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Treatment was administered for the first six weeks of the 8-week study. Patients were instructed to continue smoking for the first two weeks of treatment.
Patients were randomised into one of the following groups:
1. 21 mg nicotine + 6 mg mecamylamine
2. 21 mg nicotine + 3 mg mecamylamine
3. 21 mg nicotine + 0 mg mecamylamine
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Primary outcome measure(s)
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Analysis of the four-week continuous abstinence for the intent-to-treat population using the slip definition, which allows smoking in the first two weeks after the quit date.
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Secondary outcome measure(s)
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Analysis of the four-week continuous abstinence for the intent-to-treat population using the strict definition (no smoking after the quit date).
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Sources of funding
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Elan Corp (USA)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17506156
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Contact name
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Dr
Elbert D
Glover
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Address
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University of Maryland
2387 HHP Building
College Park
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City/town
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Maryland
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Zip/Postcode
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20742
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Country
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United States of America
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Tel
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+1 301 405 2467
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Fax
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+1 301 314 9167
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Email
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eglover1@umd.edu
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Sponsor
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Elan Corp (USA)
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Address
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Medical Affairs
7475 Lush Boulevard
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City/town
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San Diego
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Zip/Postcode
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92121
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Country
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United States of America
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Tel
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+1 858 457 2555
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Email
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mcdermottg@iconus.com
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Date applied
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03/05/2006
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Last edited
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19/03/2010
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Date ISRCTN assigned
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05/06/2006
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