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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: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00562094
First received: November 12, 2007
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562094

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

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

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Sleep 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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013