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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

November 12, 2007
May 4, 2012
October 2007
April 2009   (final data collection date for primary outcome measure)
  • Assessment of the Severity of Sleep Disturbances [ Time Frame: first and last visit (after a median of 18 days) ] [ Designated as safety issue: No ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
  • Assessment of Change of Quality of Sleep During Therapy With Pantoprazole [ Time Frame: last visit (after a median of 18 days) ] [ Designated as safety issue: No ]

    Physician's assessment on a scale with

    • considerably improved
    • improved
    • unchanged
Treatment success of reflux-associated symptomatic sleep disorders [ Time Frame: after 7 to 14 days ]
Complete list of historical versions of study NCT00562094 on ClinicalTrials.gov Archive Site
  • Assessment of the Severity of Heartburn [ Time Frame: first and last visit (after a median of 18 days) ] [ Designated as safety issue: No ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
  • Assessment of the Severity of Eructation/Acid Eructation [ Time Frame: first and last visit (after a median of 18 days) ] [ Designated as safety issue: No ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
  • Assessment of the Severity of Epigastric Complaints/Epigastric Pain [ Time Frame: first and last visit (after a median of 18 days) ] [ Designated as safety issue: No ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
  • Assessment of the Severity of Sensation of Fullness/Abdominal Distension [ Time Frame: first and last visit (after a median of 18 days) ] [ Designated as safety issue: No ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
  • Assessment of the Efficacy of Pantoprazole at Final Visit [ Time Frame: last visit (after a median of 18 days) ] [ Designated as safety issue: No ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
  • Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: last visit (after a median of 18 days) ] [ Designated as safety issue: Yes ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
GERD-associated symptoms such as heartburn, feeling of fullness, belching, and upper abdominal complaints [ Time Frame: before and after treatment ]
Not Provided
Not Provided
 
Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)
Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.

The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Outpatients

  • Erosive Gastroesophageal Reflux Disease
  • Non-Erosive Reflux Disease
Drug: Pantoprazole
This was an observational study. Therefore, the physician decided about dosage according to individual needs.
Pantoprazole
Intervention: Drug: Pantoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8616
April 2009
April 2009   (final data collection date for primary outcome measure)

Main inclusion criteria:

  • GERD
  • NERD

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00562094
PAN 20/40 PULS 07/10
No
Medical Responsible, Nycomed Deutschland GmbH
Nycomed
Not Provided
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
Nycomed
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP