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Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

NCT00749463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-07-13

Study results available
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Summary

To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

Conditions

  • Tobacco Dependence

Interventions

DRUG

Nicotine Gum

2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks

DRUG

Nicotine Patch

Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Jackie Mao · Shanghai Johnson & Johnson Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749463 on ClinicalTrials.gov