NCT01228617

Brief Summary

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

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 Sep 2007

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

September 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

1 month

First QC Date

October 25, 2010

Last Update Submit

October 4, 2011

Conditions

Tobacco Dependence

Keywords

Smoking CessationNicotine pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Maximum Concentration

    The maximum observed nicotine concentration in plasma (Cmax)

    Baseline to 10 hours post-dose

  • 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∞)

    10 hours post-dose

Secondary Outcomes (3)

  • Time to Maximum Concentration

    10 hours post-dose

  • Residual Nicotine

    30 minutes

  • Dissolution Time

    10 hours post-dose

Study Arms (7)

A1 Short, no buffer

EXPERIMENTAL

Nicotine / not yet marketed

Drug: Nicotine

A2 Short, low buffer

EXPERIMENTAL

Nicotine / not yet marketed

Drug: Nicotine

A3 Short, high buffer

EXPERIMENTAL

Nicotine / not yet marketed

Drug: Nicotine

B1 Long, no buffer

EXPERIMENTAL

Nicotine / not yet marketed

Drug: Nicotine

B2 Long, low buffer

EXPERIMENTAL

Nicotine / not yet marketed

Drug: Nicotine

B3 Long, high buffer

EXPERIMENTAL

Nicotine / not yet marketed

Drug: Nicotine

R = Nicotine Gum

ACTIVE COMPARATOR

Nicorette® Gum

Drug: Nicotine Gum

Interventions

NicotineDRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

Also known as: Not yet marketed
A1 Short, no bufferA2 Short, low bufferA3 Short, high bufferB1 Long, no bufferB2 Long, low bufferB3 Long, high buffer
Nicotine GumDRUG

Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.

Also known as: Nicorette®
R = Nicotine Gum

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Unit, Clinical Research and Trial Centre

Lund, SE-221 85, Sweden

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

NicotineNicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Elisabeth Kruse, PhD

    McNeil AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

September 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

SE(1)