Oral Tolerability Of Two Nicotine Dosage Forms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00682461
First received: May 20, 2008
Last updated: January 24, 2013
Last verified: January 2013

May 20, 2008
January 24, 2013
September 2007
January 2009   (final data collection date for primary outcome measure)
  • Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1 [ Time Frame: From baseline to Week 1 ] [ Designated as safety issue: Yes ]
    Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
  • Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6 [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: Yes ]
    Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
  • Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: Yes ]
    Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
  • Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14 [ Time Frame: From baseline to Week 14 ] [ Designated as safety issue: Yes ]
    Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
The primary objective is to assess the overall incidence and intensity of oral soft tissue related adverse events with the two nicotine dosage forms occurring during the treatment period.
Complete list of historical versions of study NCT00682461 on ClinicalTrials.gov Archive Site
Percentage of Participants With Adverse Events [ Time Frame: From baseline to Week 14 ] [ Designated as safety issue: Yes ]

Adverse Event=any untoward medical occurrence in a subject following administration of an investigational product, which did not necessarily have a causal relationship with this treatment.

Serious Adverse Event=any untoward medical occurrence that at any dose; results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect

The secondary objective is to assess the overall incidence and intensity of all adverse events with the two nicotine dosage forms occurring during the treatment period.
Not Provided
Not Provided
 
Oral Tolerability Of Two Nicotine Dosage Forms
A Randomized, Open Label Study to Evaluate the Oral Tolerability of a Nicotine Prototype

This study is to evaluate the oral tolerability of a nicotine prototype

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer Smokers
  • Drug: Nicotine
    Marketed nicotine replacement therapy formulation
    Other Name: marketed NRT formulation
  • Drug: Nicotine
    Nicotine prototype
    Other Name: Nicotine prototype
  • Active Comparator: Marketed formulation
    Marketed nicotine replacement therapy product
    Intervention: Drug: Nicotine
  • Experimental: prototype
    Nicotine prototype
    Intervention: Drug: Nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age:Males and females aged at least 18 years.
  • Smoking status: a.Must have smoked 5 to 20 cigarettes per day for the previous 12 months. b.Must be motivated to quit smoking upon randomization into study.
  • Contraception:Females of childbearing potential who have been, in the opinion of the investigator, practicing a reliable method of contraception for at least two months prior to study participation and must agree to remain on an acceptable method of contraception while participating in the study period using the study medication. Acceptable methods of contraception are hormonal birth control, intrauterine device, double barrier methods, vasectomized partner or abstinence.
  • Oral health:Must have good oral health (in the opinion of the Investigator) with no clinically significant oral pathology at screening.
  • General health:Must have good general health (in the opinion of the Investigator) with no clinically significant and relevant abnormalities of medical history on physical examination at screening.
  • Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

Exclusion Criteria:

  • Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Females of child-bearing potential will be required to undergo a urine pregnancy test which must be negative.
  • Breast-feeding:Women who are breast-feeding.
  • Nicotine use: a.Is unable/unwilling to stop using forms of tobacco. b.Is unable/unwilling to stop using other nicotine replacement therapy.
  • Disease:Has a medical history, which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results, e.g. known history of heart disease, recent myocardial infarction or cerebrovascular accident (i.e. within 12 weeks prior to the first study session), unstable angina, severe cardiac arrhythmia, diabetes or peptic ulcer.
  • Oral condition: a.Has history of oral surgery (including extractions) within four weeks, operative dental work within seven days, or a presence of any clinically significant oral pathology (as determined by the Investigator) including lesions, sores or inflammation which would interfere with assessments. b.Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with the placement or wearing of the product. c.Has current or recurrent disease that could affect the site of application, the action, absorption or disposition of the study treatment, or clinical assessment. d.Has severe gingivitis, periodontitis or rampant caries, as diagnosed by the investigator. e.Has the presence of oral or peri-oral ulceration including herpetic lesions at the time of baseline (subjects with these lesions may be re-examined at a subsequent appointment and may be able to be admitted at a later date if the ulceration or herpetic lesion heals). f.Has elective dentistry scheduled during the study duration.
  • Allergy/Intolerance: a.Has a known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. b.Presence of a genetic deficiency with an inability to metabolize aspartame or phenylalanine or has been diagnosed with phenylketonuria.
  • Clinical Study/Experimental medication: a.Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. b.Previous participation in this study.
  • Substance abuse: a) Current or recent (within two year of screening) alcohol or other substance abuse. b) Positive alcohol breath screen. c) Positive urine drug screen for cannabinoids, amphetamine, cocaine, ecstasy, methamphetamine or morphine.
  • Urine glucose:Positive glucose urine screen.
  • Personnel: a.Is an employee of the sponsor or the study site. b.Is a member of the same household as another subject in this trial.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00682461
S2110367
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP