AN EVALUATOR-BLINDED, OPEN, RANDOMIZED, PARALLEL CONTROLLED STUDY ON NICORETTE® FRESHMINT GUM VS NICORETTE® MICROTAB IN HEALTHY SMOKERS MOTIVATED TO QUIT SMOKING AND WITH VISIBLE STAINING OF TEETH

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-001040-23-IE
• Date of registration: 11/05/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer Consumer Healthcare, Pfizer Health AB
• Public title: AN EVALUATOR-BLINDED, OPEN, RANDOMIZED, PARALLEL CONTROLLED STUDY ON NICORETTE® FRESHMINT GUM VS NICORETTE® MICROTAB IN HEALTHY SMOKERS MOTIVATED TO QUIT SMOKING AND WITH VISIBLE STAINING OF TEETH
• Scientific title: AN EVALUATOR-BLINDED, OPEN, RANDOMIZED, PARALLEL CONTROLLED STUDY ON NICORETTE® FRESHMINT GUM VS NICORETTE® MICROTAB IN HEALTHY SMOKERS MOTIVATED TO QUIT SMOKING AND WITH VISIBLE STAINING OF TEETH
• Date of first enrolment: 08/06/2005
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001040-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Ireland

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Males and females of 18 to 65 years of age,
2. Daily smoker (regular smoker, smoking cigarettes every day)
3. Current daily smoking for at least 1 year
4. Declared motivation to quit smoking
5. Normal chewing abilities (ability to use chewing gums without any problem)
6. Willing to use nicotine gum or nicotine sublingual tablet
7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
8. Willing and able to comply with scheduled visits, treatment plan, tests, and other study procedures
9. Willing to refrain from a dental prophylaxis for the duration of the study.
10. A minimum of 20 natural teeth, with at least 10 of the 12 anterior teeth present and scorable (#6-#11, #22-#27). The test teeth are the 8 incisors. If one of the 8 incisors is not present or scorable, a cuspid may be substituted. Teeth that are grossly carious, fully crowned, or extensively restored on the facial or lingual surfaces will not be included in the tooth count.
11. A total extrinsic facial tooth stain score = 28, according to the MacPherson Modification of the Lobene Stain Index.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the trial:
1. Use of other tobacco containing products e.g. cigars, pipe, smokeless tobacco products
2. Current use of any nicotine replacement products, NRT, for smoking cessation or undergoing any treatment for tobacco dependence e.g. hypnosis, acupuncture, or using bupropion
3. Unstable angina pectoris or myocardial infarction during the last 3 months
4. Pregnancy, lactation or intended pregnancy
5. Any major metabolic disease, clinically important renal or hepatic disease
6. Suspected alcohol or drug abuse
7. Participation in other clinical trials the last three months and during study participation
8. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
9. Orthodontic appliances.
10. Gross periodontal disease or signs of gross oral neglect.
11. History of Oral Cancer.
12. History of Tempro-Mandibular Joint disorders (note: excessive chewing is known to aggraviate jaw pain).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Nicotine dependance.
MedDRA version: 8.0 Level: PT Classification code 10057852

Intervention(s)

Trade Name: Nicorette Freshmint Gum 2mg
Product Name: Nicorette Freshmint Gum 2mg
Pharmaceutical Form: Medicated chewing-gum
INN or Proposed INN: (S)-3-(l-Methylpyrrolidin-2-yl)pyridine
CAS Number: 54-11-5
Other descriptive name: Nicotine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Nicorette Freshmint Gum 4mg
Product Name: Nicorette Freshmint Gum 4mg
Pharmaceutical Form: Medicated chewing-gum
INN or Proposed INN: (S)-3-(l-Methylpyrrolidin-2-yl)pyridine
CAS Number: 54-11-5
Other descriptive name: Nicotine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Nicorette Microtab 2mg
Product Name: Nicorette Microtab 2mg
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: Nicotine B-cyclodextrin complex
Other descriptive name: Nicotine B-cyclodextrin complex
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Main Objective: To assess, by the MacPherson Modification of the Lobene Stain Index (9, 10), the amount of extrinsic tooth stain reduction from baseline while quitting smoking using Nicorette® Freshmint, and Nicorette® Microtab.

Secondary Objective: •To assess change in tooth shade, by the Vita® Shade Guide (11), from baseline while quitting
smoking using Nicorette® Freshmint, and Nicorette® Microtab
•To assess teeth staining / shade in relation to usage of gums
•To assess gum usage pattern
•To assess smoking status
•To assess safety

Primary end point(s): Mean change in modified extrinsic tooth stain score (total) from baseline at 6 weeks.

Secondary ID(s)

A6431085