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Nicotine gum

Phase 3

Smoking Cessation | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Apr 25, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment314

FDA Designations

No designations recorded

Clinical trial landscape

Nicotine gum · 1 trial · 1 indication

Phase 3 1
NCT00840242Smoking Reduction or Cessation With Nicotine Replacement TherapySmoking Cessation
COMPLETED314 Analytics
PHASE3COMPLETED
Smoking Reduction or Cessation With Nicotine Replacement Therapy
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Baseline to 6 weeks, 3 and 4 months

Secondary Endpoints

Changes in laboratory values of cardiovascular risk factors
Baseline up to 12 months
Changes in clinical and laboratory exposure parameters
Baseline up to 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nicotine gumEXPERIMENTALNicotine gum
Placebo gumPLACEBO_COMPARATORPlacebo gum
Nicotine inhalerACTIVE_COMPARATORNicotine inhaler
Placebo inhalerPLACEBO_COMPARATORPlacebo inhaler

Interventions

NameTypeDescription
Nicotine gumDRUG8-12 pieces per day, maximum 24 daily
Placebo gumDRUG8-12 pieces per day, maximum 24 daily
Nicotine inhalerDRUG6-12 cartridges per day, maximum 12 daily
Placebo inhalerDRUG6-12 cartridges per day, maximum 12 daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age above 18 * Smoking \>/= 15 cigarettes/day * Having smoked for 3 years or more * CO \>/= 10ppm at inclusion * Want to reduce smoking * Prepared to adhere to the protocol * Willing to provide signed informed consent * Having made at least one serious attempt to quit smoking ...

Countries:Czechia
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Frequently asked questions about Nicotine gum

What is Nicotine gum used for?

Nicotine gum is used for smoking cessation. It is a small molecule therapy being developed by Johnson & Johnson (NYSE: JNJ) as a nicotine replacement treatment to help people stop smoking. The drug is currently in Phase 3 clinical development and is being studied in patients who want to quit smoking.

How does Nicotine gum work?

Nicotine gum works by delivering nicotine to the body to replace the nicotine obtained from cigarettes, reducing withdrawal symptoms and cravings associated with smoking cessation. It is a nicotine replacement therapy that helps smokers gradually reduce their nicotine dependence. The gum is administered orally and releases nicotine as it is chewed.

Who makes Nicotine gum?

Nicotine gum is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. Johnson & Johnson is conducting clinical trials to evaluate the safety and efficacy of nicotine gum for smoking cessation.

What phase is Nicotine gum in?

Nicotine gum is in Phase 3 clinical development for smoking cessation. It is an investigational drug that has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory approval.

What clinical trials is Nicotine gum in?

Nicotine gum has one completed Phase 3 clinical trial, identified as NCT00840242, titled "Smoking Reduction or Cessation With Nicotine Replacement Therapy." The trial enrolled 314 participants in Czechia and was a randomized, double-blind, placebo-controlled study. The trial included adults aged 18 years and older of all sexes.

Is Nicotine gum the same as nicotine replacement therapy?

Nicotine gum is a form of nicotine replacement therapy (NRT). NRT is a class of medications that deliver nicotine to the body without the harmful chemicals found in tobacco smoke. Nicotine gum specifically delivers nicotine through chewing, helping to reduce withdrawal symptoms and cravings during smoking cessation.