Tobacco DependenceNCT01152749
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
A study testing Nicotine and Nicotine Gum in people with Tobacco Dependence, run by McNeil AB at 1 site in Sweden.
Trial summary
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum. 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?
- Nicotine and Nicotine Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to May 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 body mass index (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
1 site in 1 country.
About this study
Official title: Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
Read the detailed description
The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine, Nicotine Gum
- 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.
NicotineDrug
Also called Nicotine NRT / not yet marketed
Single-dose of new NRT product
Nicotine GumDrug
Also called Nicorette® Gum
Single-dose of marketed nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| UNG-GC-2 | Experimental | 2 mg experimental NRT product Receives: Drug: Nicotine |
| UNG-GC-4 | Experimental | 4 mg experimental NRT product Receives: Drug: Nicotine |
| Nicorette® Gum-2 | Active comparator | 2 mg Nicorette® Gum Receives: Drug: Nicotine Gum |
| Nicorette® Gum-4 | Active comparator | 4 mg Nicorette® Gum Receives: Drug: Nicotine Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic measurements
Pharmacokinetic measurements including:
- the maximum observed nicotine concentration in plasma (Cmax)
- the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)
- the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
Measured: Baseline and during 10 hours after product administration
Secondary outcomes (3)
tmax
The time of occurrence of Cmax following product administration
Measured: Baseline and during 10 hours after product administration
Lamda z
The terminal nicotine elimination rate constant (λz)
Measured: Baseline and during 10 hours after product administration
Released amount of nicotine
The amount of nicotine released from gums during 30 minutes' chewing.
Measured: After 30 minutes of chewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2010
- Study completionMay 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 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
- NCT01152749
- Sponsor's protocol ID
- NICTDP1075
- Other IDs
- 2009-010633-44, 2009
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 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
- Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.
- ClinicalTrials.gov ID
- NCT01152749
- Acronym / sponsor ID
- NICTDP1075
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Jun 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.
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
Detailed description
The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UNG-GC-2 | Experimental | Drug: Nicotine2 mg experimental NRT product |
| UNG-GC-4 | Experimental | Drug: Nicotine4 mg experimental NRT product |
| Nicorette® Gum-2 | Active comparator | Drug: Nicotine Gum2 mg Nicorette® Gum |
| Nicorette® Gum-4 | Active comparator | Drug: Nicotine Gum4 mg Nicorette® Gum |
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 body mass index (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 |
|---|---|---|
| NicotineAlso: Nicotine NRT / not yet marketedSingle-dose of new NRT product | Drug | UNG-GC-2, UNG-GC-4 |
| Nicotine GumAlso: Nicorette® GumSingle-dose of marketed nicotine gum | Drug | Nicorette® Gum-2, Nicorette® Gum-4 |
Primary outcome
Pharmacokinetic measurements
Time frame: Baseline and during 10 hours after product administration
Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax) * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) * the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
3 secondary outcomes
tmax
Time frame: Baseline and during 10 hours after product administration
Lamda z
Time frame: Baseline and during 10 hours after product administration
Released amount of nicotine
Time frame: After 30 minutes of chewing
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine and Nicotine Gum in people with Tobacco Dependence, run by McNeil AB at 1 site 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 1 site 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?
Pharmacokinetic measurements (time frame: Baseline and during 10 hours after product administration). 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.