Tobacco DependenceNCT01227720
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
A study testing Experimental Nicotine Replacement Therapy (NRT) 2 mg, Experimental Nicotine Replacement Therapy (NRT) and Marketed Nicotine Lozenge in people with Tobacco Dependence, run by McNeil AB at 2 sites in Sweden.
Trial summary
Comparative pharmacokinetic study of new oral nicotine replacement therapy products. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Experimental Nicotine Replacement Therapy (NRT) 2 mg, Experimental Nicotine Replacement Therapy (NRT) and Marketed Nicotine Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesSweden
- Study dates
- Aug 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Who cannot join
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Lund University Hospital Clinical Trial Unit
Lund, SE-221 85
McNeil AB Clinical Pharmacology R&D
Lund, SE-222 20
About this study
Official title: Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
Read the detailed description
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.
- Conditions
- Tobacco Dependence
- Being tested
- Experimental Nicotine Replacement Therapy (NRT) 2 mg, Experimental Nicotine Replacement Therapy (NRT), Marketed Nicotine Lozenge
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Nicotine Replacement Therapy (NRT) 2 mgDrug
Also called Not yet marketed
2 mg Single-dose of new NRT product (NSL2L)
Experimental Nicotine Replacement Therapy (NRT)Drug
Also called Not yet marketed
4 mg Single-dose of new NRT product
Marketed Nicotine LozengeDrug
Also called NiQuitin™ lozenge
2 mg Single-dose of marketed lozenge
Marketed Nicotine LozengeDrug
Also called NiQuitin™ lozenge
4 mg Single-dose of marketed lozenge
| Study group | Role | What they receive |
|---|---|---|
| A NSL2L | Experimental | Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg Receives: Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg |
| B Lozenge | Active comparator | Marketed Nicotine Lozenge 2 mg Receives: Drug: Marketed Nicotine Lozenge |
| C NSL4M | Experimental | Experimental NRT (M) 4 mg Receives: Drug: Experimental Nicotine Replacement Therapy (NRT) |
| D Lozenge | Active comparator | Marketed Nicotine Lozenge 4 mg Receives: Drug: Marketed Nicotine Lozenge |
| E NSL4L | Experimental | Experimental NRT (L) 4 mg Receives: Drug: Experimental Nicotine Replacement Therapy (NRT) |
| F NSL4H | Experimental | Experimental NRT (H) 4 mg Receives: Drug: Experimental Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration
The maximum observed nicotine concentration in plasma (Cmax)
Measured: during 12 hours after product administration
Area under the Curve
The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
Measured: after 12 hours
Secondary outcomes (3)
Time of Maximum Concentration
The time of occurrence of maximum concentration (Tmax)
Measured: during 12 hours after start of product administration
Terminal Elimination Rate Constant
The terminal nicotine elimination rate constant (λz)
Measured: during 12 hours after start of product administration
Oral Dissolution Time
Actual time required for oral dissolution
Measured: from administration until completely dissolved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227720
- Sponsor's protocol ID
- NICTDP1076
- Status last verified
- Jul 2012
- First submitted
- 22 Oct 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.
- ClinicalTrials.gov ID
- NCT01227720
- Acronym / sponsor ID
- NICTDP1076
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
Detailed description
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A NSL2L | Experimental | Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mgExperimental Nicotine Replacement Therapy (NRT)(L) 2 mg |
| B Lozenge | Active comparator | Drug: Marketed Nicotine LozengeMarketed Nicotine Lozenge 2 mg |
| C NSL4M | Experimental | Drug: Experimental Nicotine Replacement Therapy (NRT)Experimental NRT (M) 4 mg |
| D Lozenge | Active comparator | Drug: Marketed Nicotine LozengeMarketed Nicotine Lozenge 4 mg |
| E NSL4L | Experimental | Drug: Experimental Nicotine Replacement Therapy (NRT)Experimental NRT (L) 4 mg |
| F NSL4H | Experimental | Drug: Experimental Nicotine Replacement Therapy (NRT)Experimental NRT (H) 4 mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (2 listed)
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
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 |
|---|---|---|
| Experimental Nicotine Replacement Therapy (NRT) 2 mgAlso: Not yet marketed2 mg Single-dose of new NRT product (NSL2L) | Drug | A NSL2L |
| Experimental Nicotine Replacement Therapy (NRT)Also: Not yet marketed4 mg Single-dose of new NRT product | Drug | C NSL4M, E NSL4L, F NSL4H |
| Marketed Nicotine LozengeAlso: NiQuitin™ lozenge2 mg Single-dose of marketed lozenge | Drug | B Lozenge |
| Marketed Nicotine LozengeAlso: NiQuitin™ lozenge4 mg Single-dose of marketed lozenge | Drug | D Lozenge |
Primary outcome
Maximum Plasma Concentration
Time frame: during 12 hours after product administration
The maximum observed nicotine concentration in plasma (Cmax)
Area under the Curve
Time frame: after 12 hours
The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
3 secondary outcomes
Time of Maximum Concentration
Time frame: during 12 hours after start of product administration
Terminal Elimination Rate Constant
Time frame: during 12 hours after start of product administration
Oral Dissolution Time
Time frame: from administration until completely dissolved
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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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.
Elisabeth Kruse, PhD study director
McNeil AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Nicotine Replacement Therapy (NRT) 2 mg, Experimental Nicotine Replacement Therapy (NRT) and Marketed Nicotine Lozenge in people with Tobacco Dependence, run by McNeil AB at 2 sites in Sweden.
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 3 inclusion and 2 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Plasma Concentration (time frame: during 12 hours after product administration). The study lists 2 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 10 Jul 2012.