Oral Tolerability Of Two Nicotine Dosage Forms

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00682461

First received: May 20, 2008

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Results First Received: January 24, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Healthy Volunteer Smokers
Intervention:	Drug: Nicotine

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
Participants were recruited at one clinical site in the US.

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 Mouth Strip (2.5 mg)	Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Nicotine Lozenge (2.0 mg)	Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day

Participant Flow: Overall Study

	Nicotine Mouth Strip (2.5 mg)	Nicotine Lozenge (2.0 mg)
STARTED	100	100
COMPLETED	75	69
NOT COMPLETED	25	31
Adverse Event	5	7
Lost to Follow-up	8	5
Withdrawal by Subject	12	19

Baseline Characteristics

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Reporting Groups

	Description
Nicotine Mouth Strip (2.5 mg)	Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Nicotine Lozenge (2.0 mg)	Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Total	Total of all reporting groups

Baseline Measures

	Nicotine Mouth Strip (2.5 mg)	Nicotine Lozenge (2.0 mg)	Total
Number of Participants [units: participants]	100	100	200
Age [units: Years] Mean ± Standard Deviation	42.32 ± 11.79	42.84 ± 12.34	42.58 ± 12.042
Gender [units: Participants]
Female	62	63	125
Male	38	37	75

Outcome Measures

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1. Primary:

Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1 [ Time Frame: From baseline to Week 1 ]

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2. Primary:

Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6 [ Time Frame: From baseline to Week 6 ]

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3. Primary:

Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12 [ Time Frame: From baseline to Week 12 ]

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4. Primary:

Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14 [ Time Frame: From baseline to Week 14 ]

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5. Secondary:

Percentage of Participants With Adverse Events [ Time Frame: From baseline to Week 14 ]

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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. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00682461 History of Changes
Other Study ID Numbers:	S2110367
Study First Received:	May 20, 2008
Results First Received:	January 24, 2013
Last Updated:	January 24, 2013
Health Authority:	United States: Food and Drug Administration

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