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Oral Tolerability Of Two Nicotine Dosage Forms

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteer Smokers
Intervention Drug: Nicotine
Enrollment 200
Recruitment Details Participants were recruited at one clinical site in the US.
Pre-assignment Details  
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Period Title: Overall Study
Started 100 100
Completed 75 69
Not Completed 25 31
Reason Not Completed
Adverse Event             5             7
Lost to Follow-up             8             5
Withdrawal by Subject             12             19
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg) Total
Hide Arm/Group Description Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
42.32  (11.79) 42.84  (12.34) 42.58  (12.042)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
62
  62.0%
63
  63.0%
125
  62.5%
Male
38
  38.0%
37
  37.0%
75
  37.5%
1.Primary Outcome
Title Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1
Hide Description 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
Time Frame From baseline to Week 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description:
Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day
Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Number of Participants Analyzed 86 87
Measure Type: Number
Unit of Measure: Percentage
2.3 12.6
2.Primary Outcome
Title Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6
Hide Description 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
Time Frame From baseline to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description:
Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Number of Participants Analyzed 76 73
Measure Type: Number
Unit of Measure: Percentage
6.6 12.3
3.Primary Outcome
Title Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12
Hide Description 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
Time Frame From baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description:
Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Number of Participants Analyzed 75 70
Measure Type: Number
Unit of Measure: Percentage
6.7 7.1
4.Primary Outcome
Title Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14
Hide Description 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
Time Frame From baseline to Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description:
Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Number of Participants Analyzed 82 87
Measure Type: Number
Unit of Measure: Percentage
2.4 8.0
5.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description

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

Time Frame From baseline to Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description:
Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: Percentage
Oral Treatment Emergent Adverse Events 27 44
Non-oral Treatment Emergent Adverse Events 58 60
Serious Adverse Events 0 1
Death 0 0
Time Frame From baseline to Week 14
Adverse Event Reporting Description All adverse events
 
Arm/Group Title Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Hide Arm/Group Description Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
All-Cause Mortality
Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      1/100 (1.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant Melanoma  1 [1]  0/100 (0.00%)  0 1/100 (1.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
[1]
Unrelated to the study treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Nicotine Mouth Strip (2.5 mg) Nicotine Lozenge (2.0 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/100 (69.00%)      75/100 (75.00%)    
Gastrointestinal disorders     
Oral Mucosal Erythema  1  1/100 (1.00%)  2 3/100 (3.00%)  4
Dry Mouth  1  2/100 (2.00%)  2 3/100 (3.00%)  3
Gingival Ulceration  1  1/100 (1.00%)  1 3/100 (3.00%)  4
Oral Discomfort  1  3/100 (3.00%)  3 1/100 (1.00%)  1
Paraesthesia Oral  1  0/100 (0.00%)  0 4/100 (4.00%)  4
Nausea  1  11/100 (11.00%)  12 14/100 (14.00%)  17
Dyspepsia  1  6/100 (6.00%)  6 8/100 (8.00%)  8
Flatulence  1  0/100 (0.00%)  0 7/100 (7.00%)  7
Gastrointestinal Reflux Disease  1  3/100 (3.00%)  3 0/100 (0.00%)  0
Vomitting  1  0/100 (0.00%)  0 3/100 (3.00%)  3
Infections and infestations     
Gastrooenteritis Viral  1  2/100 (2.00%)  2 3/100 (3.00%)  3
Nasopharyngitis  1  17/100 (17.00%)  18 19/100 (19.00%)  20
Injury, poisoning and procedural complications     
Mouth Injury  1  5/100 (5.00%)  5 6/100 (6.00%)  8
Tooth Fracture  1  3/100 (3.00%)  3 3/100 (3.00%)  3
Nervous system disorders     
Headache  1  9/100 (9.00%)  11 4/100 (4.00%)  4
Dizziness  1  3/100 (3.00%)  3 1/100 (1.00%)  1
Psychiatric disorders     
Insomnia  1  3/100 (3.00%)  3 0/100 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Throat Irritation  1  4/100 (4.00%)  5 13/100 (13.00%)  15
Oropharyngeal Pain  1  1/100 (1.00%)  1 5/100 (5.00%)  5
Hiccups  1  4/100 (4.00%)  4 9/100 (9.00%)  12
Cough  1  2/100 (2.00%)  2 5/100 (5.00%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00682461     History of Changes
Other Study ID Numbers: S2110367
First Submitted: May 20, 2008
First Posted: May 22, 2008
Results First Submitted: January 24, 2013
Results First Posted: March 1, 2013
Last Update Posted: March 1, 2013