Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985985
First received: September 2, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.


Condition Intervention Phase
Smoking
Drug: Nicotine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Evaluate Efficacy and Safety of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rate of Successful Smoking Cessation at Week 6 [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
    Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.


Secondary Outcome Measures:
  • Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24 [ Time Frame: From baseline to Week 12 and Week 24 ] [ Designated as safety issue: No ]
    Continuous abstinence was verified by measurement of CO breath levels.

  • Rate of Long-term Successful Smoking Cessation at Week 24 [ Time Frame: From Week 6 to Week 24 ] [ Designated as safety issue: No ]
    Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.

  • Proportion of Participants With Seven Day Point Prevalence Abstinence [ Time Frame: Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24 ] [ Designated as safety issue: No ]
    Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.

  • Mean Score of Relief of Craving/ Total Withdrawal Symptoms [ Time Frame: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6 ] [ Designated as safety issue: No ]
    The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.

  • Mean Daily Dose at Visit 4, 5, 6, 7 and 10 [ Time Frame: Weeks 1-2, 3-4, 5-6, 7-12 and 13-24 ] [ Designated as safety issue: No ]
    Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.

  • Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination. [ Time Frame: Baseline, Week 6, 12 and Week 24 ] [ Designated as safety issue: No ]
    Change in body weight was analyzed at Weeks 6, 12, and 24.

  • Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs [ Time Frame: Weekly assessments from first treatment dose up to 15 days after last treatment dose ] [ Designated as safety issue: No ]
    All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.


Enrollment: 723
Study Start Date: May 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2mg nicotine lozenge
2 mg nicotine lozenge
Drug: Nicotine
2 mg or 4 mg nicotine lozenge
Placebo Comparator: 2 mg placebo
2 mg placebo
Drug: Placebo
placebo lozenge
Experimental: 4 mg nicotine lozenge
4 mg nicotine lozenge
Drug: Nicotine
2 mg or 4 mg nicotine lozenge
Placebo Comparator: 4 mg placebo
4 mg placebo
Drug: Placebo
placebo lozenge

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be 18 years of age or older;
  • Participant is motivated in smoking cessation using nicotine mint lozenge;
  • Participant has the habit of smoking regularly every day for at least 1 year;
  • Participant is able to read and provide written informed consent.

Exclusion Criteria:

  • Participant uses other forms of tobacco other than cigarettes such as pipes, cigars, snuff, or smokeless tobacco within 30 days of entry into the study;
  • Participant uses other nicotine delivery system such as nicotine gum, nicotine patch, nicotine inhaler, or nicotine nasal spray etc. within 30 days of study entry;
  • Participant smoke any other substance within 30 days of study entry (such as cannabis, cocaine, heroin, ice drug, herbal cigarettes etc);
  • The participant has a past history of alcohol or drug abuse;
  • Participants use other smoking cessation aids (including bupropion, varenicline, traditional Chinese medicines such as herbals, acupuncture, consultation etc), within 30 days of study entry.;
  • Participant is currently involved in another clinical trial or has used any investigational medication within 30 days of study entry; Any previous participation in this study;
  • Participant is a member of the same household as another clinical subject. Subject is a relative of study site staff or member of the study staff;
  • Participant is pregnant or breast-feeding, or has childbearing potential but refusing taking medical contraception measures (within first 24 weeks during study). (Note: All female subjects with childbearing potential must take urine pregnancy test before entry the study, only negative result subject is permitted to this study.);
  • Participants who have heart and cerebral vascular disease not stable or controlled by medication or have an irregular heartbeat or have had a heart attack within the last 3 months;
  • Participants with poorly controlled high blood pressure by medications, systolic BP greater than or equal to 140mmHg, diastolic BP greater than or equal to 90mmHg after administration;
  • Participants having hyperthyroidism or current application of insulin for diabetes;
  • Participants having myocardial infarction or cerebral vascular accidents recently (within the past 3 months);
  • Participants who are unable to fulfill study requirements in relation to conforming to the visit schedule;
  • Participants who are allergy to Aspartame or Phenylpyruvic acid (an edulcorant is widely used in foods and drinks),or have diagnosed with Phenylketonuria;
  • The other clinically significant pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.( unstable or worsening angina pectoris, Prinzmetal's angina, nerve or circulatory problems, rheumatoid arthritis, moderate and severe COPD);
  • A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject or the validity for the study results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985985

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985985     History of Changes
Other Study ID Numbers: CHN-Nicotine Mint Lozenge-002
Study First Received: September 2, 2009
Results First Received: July 25, 2013
Last Updated: June 19, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
smoking cessation
nicotine lozenge
nicotine replacement therapy

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014