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NCT Number: NCT00830115

Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders

The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.

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Key information

Conditions

Sleep Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Non-Erosive Reflux Disease Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Deutschland GmbH, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main inclusion criteria:

  • Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)

Main exclusion criteria:

  • Criteria as defined in the respective Summary of Product Characteristics (Chapter 4.3)

Treatment and study plan

Pantoprazole

Drug

Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Primary outcomes

  1. Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts

  2. Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  3. Physician's Assessment of Sleep Disturbances

    Time frame: 7 days

    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

Secondary outcomes

  1. Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad

  2. Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  3. Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  4. Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  5. Patient's Assessment of Nausea for the Last 24 Hours (Diaries)

    Time frame: 7 days

    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  6. Physician's Assessment of Heartburn

    Time frame: 7 days

    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  7. Physician's Assessment of Acid Eructation

    Time frame: 7 days

    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  8. Physician's Assessment of Painful Swallowing

    Time frame: 7 days

    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  9. Assessment of the Efficacy of Pantoprazole at Final Visit

    Time frame: 7 days

    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  10. Assessment of the Tolerability of Pantoprazole at Final Visit

    Time frame: 7 days

    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

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

Acronym: PANDA

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2009
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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