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Completed

NCT Number: NCT00562094

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

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.

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Key information

Conditions

Erosive Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux 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:

  • GERD
  • NERD

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics

Treatment and study plan

Pantoprazole

Drug

This was an observational study. Therefore, the physician decided about dosage according to individual needs.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.

Acronym: PULS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2007
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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