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Completed

NCT Number: NCT00561730

Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)

The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Non-Erosive Reflux Disease

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 according to Los Angeles classification grade A-D) or non-erosive reflux disease (NERD)

Main exclusion criteria:

  • Criteria as defined in the 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 General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)

    Time frame: 7 days

    Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad

  2. Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)

    Time frame: 7 days

    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  3. Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)

    Time frame: 7 days

    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  4. Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)

    Time frame: 7 days

    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  5. Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)

    Time frame: 7 days

    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  6. Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)

    Time frame: 7 days

    Assessment on a scale: Severity from 0=None to 10=Extremely strong

Secondary outcomes

  1. Physician's Assessment of Heartburn

    Time frame: 7 days

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

  2. Physician's Assessment of Acid Eructation

    Time frame: 7 days

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

  3. Physician's Assessment of Painful Swallowing

    Time frame: 7 days

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

  4. Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit

    Time frame: 7 days

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

  5. Assessment of the Tolerability of Pantoprazole 20 mg/40 mg 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

Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)

Acronym: PANTHER

Important dates

Study start
2007
Study completion
2008
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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