Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00562094
First received: November 12, 2007
Last updated: May 4, 2012
Last verified: May 2012
Results First Received: September 1, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Erosive Gastroesophageal Reflux Disease
Non-Erosive 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
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Reporting Groups
  Description
Pantoprazole All patients enrolled

Participant Flow:   Overall Study
    Pantoprazole  
STARTED     8616  
COMPLETED     8554  
NOT COMPLETED     62  
Lost to Follow-up                 62  



  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
Pantoprazole All patients enrolled

Baseline Measures
    Pantoprazole  
Number of Participants  
[units: participants]
  8616  
Age [1]
[units: years]
Mean ± Standard Deviation
  55.7  ± 14.51  
Gender, Customized  
[units: percentage of participants]
 
Female     47.8  
Male     51.7  
Missing data     0.5  
Nicotine use  
[units: percentage of participants]
 
Smoker     35.2  
Non-smoker     64.1  
Missing data     0.7  
Alcohol use  
[units: percentage of participants]
 
Daily     22.1  
Not daily     77.2  
Missing data     0.8  
Drug abuse  
[units: percentage of participants]
 
Drug abuse     2.9  
No drug abuse     96.0  
Missing data     1.1  
Indication for prescription of pantoprazole  
[units: percentage of participants]
 
long-term therapy and/or relapse prophylaxis     50.5  
Acute reflux oesophagitis     49.1  
Missing data     0.4  
[1] The measured value is related to the number of 8502 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 114 subjects.



  Outcome Measures
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1.  Primary:   Assessment of the Severity of Sleep Disturbances   [ Time Frame: first and last visit (after a median of 18 days) ]

2.  Primary:   Assessment of Change of Quality of Sleep During Therapy With Pantoprazole   [ Time Frame: last visit (after a median of 18 days) ]

3.  Secondary:   Assessment of the Severity of Heartburn   [ Time Frame: first and last visit (after a median of 18 days) ]

4.  Secondary:   Assessment of the Severity of Eructation/Acid Eructation   [ Time Frame: first and last visit (after a median of 18 days) ]

5.  Secondary:   Assessment of the Severity of Epigastric Complaints/Epigastric Pain   [ Time Frame: first and last visit (after a median of 18 days) ]

6.  Secondary:   Assessment of the Severity of Sensation of Fullness/Abdominal Distension   [ Time Frame: first and last visit (after a median of 18 days) ]

7.  Secondary:   Assessment of the Efficacy of Pantoprazole at Final Visit   [ Time Frame: last visit (after a median of 18 days) ]

8.  Secondary:   Assessment of the Tolerability of Pantoprazole at Final Visit   [ Time Frame: last visit (after a median of 18 days) ]


  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 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.


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: NCT00562094     History of Changes
Other Study ID Numbers: PAN 20/40 PULS 07/10
Study First Received: November 12, 2007
Results First Received: September 1, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices