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Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01037452
First received: December 22, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
Results First Received: December 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Heartburn
Interventions: Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Drug: Lansoprazole
Drug: Calcium carbonate/magnesium hydroxide
Drug: Placebo

  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
Combination Product Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
PPI Alone Lansoprazole 15 mg, single dose
Antacid Alone Calcium carbonate/magnesium hydroxide, single dose
Placebo Placebo, single dose

Participant Flow:   Overall Study
    Combination Product     PPI Alone     Antacid Alone     Placebo  
STARTED     30     30     30     30  
COMPLETED     30     30     30     30  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Combination Product Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
PPI Alone Lansoprazole 15 mg, single dose
Antacid Alone Calcium carbonate/magnesium hydroxide, single dose
Placebo Placebo, single dose
Total Total of all reporting groups

Baseline Measures
    Combination Product     PPI Alone     Antacid Alone     Placebo     Total  
Number of Participants  
[units: participants]
 		  30     30     30     30     120  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     30     30     30     29     119  
>=65 years     0     0     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation 		  33.7  ± 11.5     30.4  ± 11.1     30.9  ± 13.3     31.9  ± 12.6     31.7  ± 12.1  
Gender  
[units: participants]
 		         
Female     15     14     11     17     57  
Male     15     16     19     13     63  
Region of Enrollment  
[units: participants]
 		         
United States     30     30     30     30     120  



  Outcome Measures
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1.  Primary:   Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal   [ Time Frame: 1 day ]
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2.  Secondary:   Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals   [ Time Frame: 1 day ]
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3.  Secondary:   Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn   [ Time Frame: 1 day ]
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4.  Secondary:   Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.   [ Time Frame: 1 day ]
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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:
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.
unchecked 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: Head New Therapeutic Opportunities
Organization: Novartis
phone: 973-503-8000


No publications provided


Responsible Party: Head, New Therapeutic Opportunities, Novartis
ClinicalTrials.gov Identifier: NCT01037452     History of Changes
Other Study ID Numbers: 145-G-201
Study First Received: December 22, 2009
Results First Received: December 14, 2010
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration