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Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease (PARADE)

This study has been completed.
Sponsor:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00829738
First received: January 13, 2009
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
Results First Received: September 1, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Gastroesophageal Reflux Disease
Intervention: Drug: Pantoprazole

  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
All patients were evaluated, missing values were not imputed.

Reporting Groups
  Description
Pantoprazole All patients enrolled

Participant Flow:   Overall Study
    Pantoprazole  
STARTED     4188  
COMPLETED     4180  
NOT COMPLETED     8  



  Baseline Characteristics
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Reporting Groups
  Description
Pantoprazole All patients enrolled

Baseline Measures
    Pantoprazole  
Number of Participants  
[units: participants]
 		  4188  
Age [1]
[units: years]
Mean ± Standard Deviation 		  55.3  ± 14.82  
Gender, Customized  
[units: percentage of participants]
 		 
Female     47.6  
Male     52.0  
Missing data     0.4  
Nicotine use  
[units: percentage of participants]
 		 
Smoker     36.7  
Non-smoker     62.8  
Missing data     0.4  
Alcohol use  
[units: percentage of participants]
 		 
Daily     21.9  
Not daily     77.4  
Missing data     0.6  
Drug abuse  
[units: percentage of participants]
 		 
Drug abuse     3.6  
No drug abuse     95.5  
Missing data     0.9  
Indication for prescription of pantoprazole  
[units: percentage of participants]
 		 
Long-term therapy and/or relapse prophylaxis     39.8  
Acute reflux oesophagitis     57.2  
Missing data     3.0  
[1] The measured value is related to the number of 4125 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 63 subjects.



  Outcome Measures
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1.  Primary:   Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn   [ Time Frame: 14 days ]
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2.  Primary:   Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation   [ Time Frame: 14 days ]
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3.  Primary:   Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing   [ Time Frame: 14 days ]
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4.  Primary:   Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms   [ Time Frame: 14 days ]
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5.  Secondary:   Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain   [ Time Frame: 14 days ]
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6.  Secondary:   Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness   [ Time Frame: 14 days ]
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7.  Secondary:   Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea   [ Time Frame: 14 days ]
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8.  Secondary:   Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms   [ Time Frame: 14 days ]
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9.  Secondary:   Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain   [ Time Frame: 14 days ]
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10.  Secondary:   Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea   [ Time Frame: 14 days ]
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11.  Secondary:   Irritable Bowel Syndrome: Assessment of the Severity of Constipation   [ Time Frame: 14 days ]
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12.  Secondary:   Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome   [ Time Frame: 14 days ]
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13.  Secondary:   Assessment of the Tolerability of Pantoprazole at Final Visit   [ Time Frame: 14 days ]
  Show Outcome Measure 13


  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 NOT 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.


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: Medical Responsible
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com


No publications provided


Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00829738     History of Changes
Other Study ID Numbers: P2-9999-011-DE
Study First Received: January 13, 2009
Results First Received: September 1, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices