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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562094
First Posted: November 21, 2007
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nycomed
  Purpose
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.

Condition Intervention
Erosive Gastroesophageal Reflux Disease Non-Erosive Reflux Disease Drug: Pantoprazole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.

Resource links provided by NLM:


Further study details as provided by Nycomed:

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

    Physician's assessment on a scale with

    • considerably improved
    • improved
    • unchanged


Secondary Outcome Measures:
  • Assessment of the Severity of Heartburn [ Time Frame: first and last visit (after a median of 18 days) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory


Enrollment: 8616
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pantoprazole Drug: Pantoprazole
This was an observational study. Therefore, the physician decided about dosage according to individual needs.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients
Criteria

Main inclusion criteria:

  • GERD
  • NERD

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562094


  Show 1153 Study Locations
Sponsors and Collaborators
Nycomed
Investigators
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00562094     History of Changes
Other Study ID Numbers: PAN 20/40 PULS 07/10
First Submitted: November 12, 2007
First Posted: November 21, 2007
Results First Submitted: September 1, 2010
Results First Posted: September 24, 2010
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Nycomed:
Pantoprazole
eGERD (Erosive Gastroesophageal Reflux Disease)
NERD (Non-Erosive Reflux Disease)
sleep disorders

Additional relevant MeSH terms:
Gastroesophageal Reflux
Sleep Wake Disorders
Parasomnias
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action