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Oral Tolerability Of Two Nicotine Dosage Forms

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: NCT00682461
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : March 1, 2013
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 20, 2008
First Posted Date  ICMJE May 22, 2008
Results First Submitted Date  ICMJE January 24, 2013
Results First Posted Date  ICMJE March 1, 2013
Last Update Posted Date March 1, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
  • Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1 [ Time Frame: From baseline to Week 1 ]
    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 ]
    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 ]
    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 ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
Percentage of Participants With Adverse Events [ Time Frame: From baseline to Week 14 ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Tolerability Of Two Nicotine Dosage Forms
Official Title  ICMJE A Randomized, Open Label Study to Evaluate the Oral Tolerability of a Nicotine Prototype
Brief Summary This study is to evaluate the oral tolerability of a nicotine prototype
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer Smokers
Intervention  ICMJE
  • Drug: Nicotine
    Marketed nicotine replacement therapy formulation
    Other Name: marketed NRT formulation
  • Drug: Nicotine
    Nicotine prototype
    Other Name: Nicotine prototype
Study Arms  ICMJE
  • Active Comparator: Marketed formulation
    Marketed nicotine replacement therapy product
    Intervention: Drug: Nicotine
  • Experimental: prototype
    Nicotine prototype
    Intervention: Drug: Nicotine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00682461
Other Study ID Numbers  ICMJE S2110367
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2013

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