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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

ClinicalTrials.gov Identifier:

NCT00749463

First received: September 8, 2008

Last updated: July 6, 2012

Last verified: July 2012

History of Changes

Results First Received: April 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Tobacco Dependence
Interventions:	Drug: Nicotine Gum Drug: Nicotine Patch

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Nicotine Gum 2	Dosage: 2 mg, Dosage Form: Gum
Nicotine Gum 4	Dosage: 4 mg, Dosage Form: Gum
Nicotine Patch	Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch

Participant Flow: Overall Study

	Nicotine Gum 2	Nicotine Gum 4	Nicotine Patch
STARTED	86	64	150
COMPLETED	85	60	149
NOT COMPLETED	1	4	1
Adverse Event	0	4	1
Withdrawal by Subject	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Nicotine Gum 2	Dosage: 2 mg, Dosage Form: Gum
Nicotine Gum 4	Dosage: 4 mg, Dosage Form: Gum
Nicotine Patch	Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
Total	Total of all reporting groups

Baseline Measures

	Nicotine Gum 2	Nicotine Gum 4	Nicotine Patch	Total
Number of Participants [units: participants]	86	64	150	300
Age [units: years] Mean ± Standard Deviation	40.6 ± 10.2	40.3 ± 10.0	41.7 ± 11.6	41.1 ± 10.9
Gender [units: participants]
Female	0	2	1	3
Male	86	62	149	297
Region of Enrollment [units: participants]
China	86	64	150	300

Outcome Measures

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1. Primary:

Treatment-Related Adverse Events [ Time Frame: 24 Weeks ]

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2. Primary:

Self-Reported Smoking Reduction [ Time Frame: 24 Weeks ]

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3. Primary:

Smoking Abstinence [ Time Frame: 24 Weeks ]

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Measure Type	Primary
Measure Title	Smoking Abstinence
Measure Description	Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
Time Frame	24 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Nicotine Gum 2	Dosage: 2 mg, Dosage Form: Gum
Nicotine Gum 4	Dosage: 4 mg, Dosage Form: Gum
Nicotine Patch	Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch

Measured Values

	Nicotine Gum 2	Nicotine Gum 4	Nicotine Patch
Number of Participants Analyzed [units: participants]	86	64	150
Smoking Abstinence [units: Participants]
Visit at 2 Weeks	24	9	34
Visit at 6 Weeks	19	7	24
Visit at 8 Weeks	18	7	24
Visit at 10 Weeks	17	7	22
Visit at 12 Weeks	16	7	21
Visit at 24 Weeks	13	7	17

No statistical analysis provided for Smoking Abstinence

4. Secondary:

Carbon Monoxide (CO)-Verified Smoking Reduction [ Time Frame: Baseline to Week 24 ]

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5. Secondary:

Smoking Consumption Per Day [ Time Frame: 24 Weeks from last visit: ]

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6. Secondary:

Smoking Consumption Per Week [ Time Frame: 24 Weeks from last visit: ]

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7. Secondary:

Point Prevalence Smoking Abstinence (PPSA) [ Time Frame: 24 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Joyce Hauze, Sr Specialist, Clinical Research Operations
Organization: J&J Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com

No publications provided

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:	NCT00749463 History of Changes
Other Study ID Numbers:	NICTDP4009
Study First Received:	September 8, 2008
Results First Received:	April 23, 2010
Last Updated:	July 6, 2012
Health Authority:	China: Ethics Committee

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