Healthy Volunteer SmokersPhase 1NCT00682461
Oral Tolerability Of Two Nicotine Dosage Forms
A Phase 1 study testing Nicotine in people with Healthy Volunteer Smokers, run by GlaxoSmithKline.
Trial summary
This study is to evaluate the oral tolerability of a nicotine prototype Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Smokers
- What is being tested?
- Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jan 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
About this study
Official title: 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
- Conditions
- Healthy Volunteer Smokers
- Being tested
- Nicotine
- Keywords
- Nicotine Tolerability NRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called marketed NRT formulation
Marketed nicotine replacement therapy formulation
NicotineDrug
Also called Nicotine prototype
Nicotine prototype
| Study group | Role | What they receive |
|---|---|---|
| Marketed formulation | Active comparator | Marketed nicotine replacement therapy product Receives: Drug: Nicotine |
| prototype | Experimental | Nicotine prototype Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Oral Soft Tissue Related Adverse Events at 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
Measured: From baseline to Week 1
Percentage of Participants With Oral Soft Tissue Related Adverse Events at 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
Measured: From baseline to Week 6
Percentage of Participants With Oral Soft Tissue Related Adverse Events at 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
Measured: From baseline to Week 12
Percentage of Participants With Oral Soft Tissue Related Adverse Events at 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
Measured: From baseline to Week 14
Secondary outcomes (1)
Percentage of Participants With Adverse Events
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
Measured: From baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Volunteer SmokersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682461
- Sponsor's protocol ID
- S2110367
- Status last verified
- Jan 2013
- First submitted
- 20 May 2008
- Last updated
- 1 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Evaluate the Oral Tolerability of a Nicotine Prototype
- ClinicalTrials.gov ID
- NCT00682461
- Acronym / sponsor ID
- S2110367
- Conditions
- Healthy Volunteer Smokers
- Keywords
- Nicotine Tolerability NRT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Posted 1 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the oral tolerability of a nicotine prototype
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed formulation | Active comparator | Drug: NicotineMarketed nicotine replacement therapy product |
| prototype | Experimental | Drug: NicotineNicotine prototype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: marketed NRT formulationMarketed nicotine replacement therapy formulation | Drug | Marketed formulation |
| NicotineAlso: Nicotine prototypeNicotine prototype | Drug | prototype |
Primary outcome
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
1 secondary outcome
Percentage of Participants With Adverse Events
Time frame: From baseline to Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine in people with Healthy Volunteer Smokers, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1 (time frame: From baseline to Week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.