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Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01448057
First received: October 5, 2011
Last updated: November 17, 2016
Last verified: November 2016
Results First Received: August 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Upper Respiratory Tract Infection
Nasal Congestion
Rhinorrhea
Sneezing
Interventions: Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg) tablets

  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
No text entered.

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
Combination Product

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets

Paracetamol Tablets

Paracetamol (500 mg) tablets

Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets


Participant Flow:   Overall Study
    Combination Product   Paracetamol Tablets
STARTED   170   171 
COMPLETED   162   167 
NOT COMPLETED   8   4 
Protocol Violation                3                2 
Lost to Follow-up                3                0 
Adverse Event                0                2 
Withdrawal by Subject                2                0 



  Baseline Characteristics
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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
Arm A

Combination Product

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets

Arm B

Paracetamol (500 mg) tablets

Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets

Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 170   171   341 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      170 100.0%      171 100.0%      341 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (11.64)   34.5  (11.76)   35.3  (11.71) 
Gender 
[Units: Participants]
Count of Participants
     
Female      122  71.8%      134  78.4%      256  75.1% 
Male      48  28.2%      37  21.6%      85  24.9% 
Region of Enrollment 
[Units: Participants]
     
Brazil   170   171   341 


  Outcome Measures
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1.  Primary:   Physician Global Evaluation of Effectiveness on Nasal Symptoms   [ Time Frame: Day 2 ]

2.  Secondary:   Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms   [ Time Frame: Day 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Director Clinical research Respiratory
Organization: Novartis consumer Health a GSK Consumer Healtcare company
phone: (1) 5512065988
e-mail: anna.x.grinienko@gsk.com



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01448057     History of Changes
Other Study ID Numbers: 381-A-301
Study First Received: October 5, 2011
Results First Received: August 16, 2016
Last Updated: November 17, 2016