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Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

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ClinicalTrials.gov Identifier: NCT00736047
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

Condition or disease Intervention/treatment Phase
Smokers Biological: NIC002 Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Actual Study Start Date : August 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: 1 Biological: NIC002
Placebo Comparator: 2 Biological: Placebo



Primary Outcome Measures :
  1. Smoking status [ Time Frame: 12 weeks ]
  2. Exhaled carbon monoxide [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Smoking status at various time intervals from target quit date to the end of the study [ Time Frame: 52 weeks ]
  2. Safety and tolerability [ Time Frame: 52 weeks ]
  3. Immunogenicity (specific anti-nicotine antibodies in serum) [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy male and female smoking subjects age 18 to 65 years of age
  • Subjects must be smoking 10 or more cigarettes per day during the past 12 months
  • The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
  • The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion Criteria:

  • Attempted to quit smoking in the three (3) months.
  • Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736047


Locations
Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigator Site
Neuss, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis Investigator Site

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00736047     History of Changes
Other Study ID Numbers: CNIC002A2201
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Novartis:
Smokers
smoking cessation
vaccine
antibodies
anti-nicotine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs