NCT01084707

Brief Summary

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 19, 2010

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

March 9, 2010

Results QC Date

April 16, 2010

Last Update Submit

July 6, 2012

Conditions

Tobacco Dependence

Keywords

Smoking Cessation, Nicotine pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration

    Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

    During the last dosing interval (hour 11-12 post-dose)

  • Average Concentration

    Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)

    During the last dosing interval (hour 11-12 post-dose)

Secondary Outcomes (4)

  • Time of Maximum Concentration

    During the last dosing interval (hour 11-12 post-dose)

  • Minimum Plasma Concentration

    During the last dosing interval (hour 11-12 post-dose)

  • Peak-Trough Fluctuation

    During the last dosing interval (hour 11-12 post-dose)

  • Nicotine Plasma Concentration

    One hour after start of treatment

Study Arms (5)

Oral Nicotine 24-SA

EXPERIMENTAL

2 Self-administrations of Experimental Nicotine once every hour

Drug: Oral Nicotine

Oral Nicotine 24

EXPERIMENTAL

2 administrations of Experimental Nicotine by study personnel once every hour

Drug: Oral Nicotine

Oral Nicotine 48

EXPERIMENTAL

2 administrations of Experimental Nicotine by study personnel once every 30 minutes

Drug: Oral Nicotine

NiQuitin™ Lozenge 4 mg

ACTIVE COMPARATOR

1 NiQuitin™ lozenge, administered by study personnel once every hour

Drug: Nicotine Lozenge

Nicorette® Gum 4 mg

ACTIVE COMPARATOR

1 piece Nicorette® gum, chewed for 30 minutes once every hour

Drug: Nicotine gum

Interventions

Oral NicotineDRUG

Oral Nicotine either self-administered or provided by study personnel within 12 hours

Also known as: generic Nicotine
Oral Nicotine 24Oral Nicotine 24-SAOral Nicotine 48
Nicotine LozengeDRUG

Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours

Also known as: NiQuitin™
NiQuitin™ Lozenge 4 mg
Nicotine gumDRUG

Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Also known as: Nicorette®
Nicorette® Gum 4 mg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Prior regular use of nicotine mouth spray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology

Lund, 222 20, Sweden

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

NicotineTobacco Use Cessation DevicesNicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingTherapeuticsChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Joyce Hauze, Sr. Specialist, Clinical Research Operations
Organization
J&J Consumer and Personal Products Worldwide
jhauze@its.jnj.com
928-277-0715

Study Officials

  • Elisabeth Kruse, PhD

    McNeil AB

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

July 13, 2012

Results First Posted

October 19, 2010

Record last verified: 2012-07

Locations

SE(1)