ClinicalTrials.gov
ClinicalTrials.gov Menu

Nicotine Mouth Film for Craving Relief.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01702532
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Smoking Cessation
Intervention: Drug: Nicotine

  Participant Flow

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 the clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 386 participants were screened of which 322 subjects were randomized into the study. Sixty subjects were screen failures, Two subjects withdrew consent and an additional 2 subjects were not randomized due to other reasons.

Reporting Groups
  Description
Nicotine Mouth Film 2.5 mg Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
Nicotine Lozenge 2 mg Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).

Participant Flow:   Overall Study
    Nicotine Mouth Film 2.5 mg   Nicotine Lozenge 2 mg
STARTED   161   161 
Safety Population   161   160 [1] 
COMPLETED   161   160 
NOT COMPLETED   0   1 
Adverse Event                0                1 
[1] One subject randomized but did not receive the study treatment.



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Nicotine Mouth Film 2.5 mg Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
Nicotine Lozenge 2 mg Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
Total Total of all reporting groups

Baseline Measures
   Nicotine Mouth Film 2.5 mg   Nicotine Lozenge 2 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   160   321 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.0  (12.91)   39.8  (12.64)   39.4  (12.76) 
Gender 
[Units: Participants]
     
Female   89   73   162 
Male   72   87   159 


  Outcome Measures

1.  Primary:   The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds   [ Time Frame: Pre-dosing post-provocation to 50 seconds ]

2.  Secondary:   The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes   [ Time Frame: Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01702532     History of Changes
Other Study ID Numbers: RH01589
First Submitted: October 4, 2012
First Posted: October 8, 2012
Results First Submitted: December 12, 2013
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014