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Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01265446
First received: December 20, 2010
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
Results First Received: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sore Throat Due to a Common Cold
Interventions: Drug: Lidocaine 8mg + CPC 2mg
Drug: Lidocaine 1mg + CPC 2mg

  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
14 Dec 2010 to 5 Apr 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lidocaine 8mg +CPC 2mg one single dose
Lidocaine 1mg + CPC 2mg one single dose

Participant Flow:   Overall Study
    Lidocaine 8mg +CPC 2mg     Lidocaine 1mg + CPC 2mg  
STARTED     125     125  
COMPLETED     124     125  
NOT COMPLETED     1     0  



  Baseline Characteristics
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Reporting Groups
  Description
Lidocaine 8mg +CPC 2mg one single dose
Lidocaine 1mg + CPC 2mg one single dose
Total Total of all reporting groups

Baseline Measures
    Lidocaine 8mg +CPC 2mg     Lidocaine 1mg + CPC 2mg     Total  
Number of Participants  
[units: participants]
 		  125     125     250  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     125     125     250  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  32.1  ± 12.6     31.6  ± 11.6     31.9  ± 12.1  
Gender  
[units: participants]
 		     
Female     67     67     134  
Male     58     58     116  
Region of Enrollment  
[units: participants]
 		     
Germany     125     125     250  



  Outcome Measures
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1.  Primary:   Change From Baseline Sore Throat Pain Intensity   [ Time Frame: Baseline and 2 hours post-dose ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose   [ Time Frame: Baseline and 240 mn post-dose ]
  Show Outcome Measure 2


  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:
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.


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.  


Results Point of Contact:  
Name/Title: Clinical Project Leader
Organization: Novartis Consumer Health, Nyon, Switzerland
phone: +41223633279
e-mail: Rowland.Furcha@novartis.com


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01265446     History of Changes
Other Study ID Numbers: 075-A-301, 2010-021653-39
Study First Received: December 20, 2010
Results First Received: March 29, 2012
Last Updated: April 17, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices