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Completed

NCT Number: NCT00829738

Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease

The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

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 gastroesophageal reflux disease (GERD)

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 (20 or 40 mg pantoprazole).

Primary outcomes

  1. Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  2. Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  3. Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  4. Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms

    Time frame: 14 days

    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Secondary outcomes

  1. Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  2. Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  3. Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  4. Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms

    Time frame: 14 days

    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  5. Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  6. Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  7. Irritable Bowel Syndrome: Assessment of the Severity of Constipation

    Time frame: 14 days

    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  8. Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome

    Time frame: 14 days

    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  9. Assessment of the Tolerability of Pantoprazole at Final Visit

    Time frame: 14 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 20/40 mg in Reflux-Associated Complaints With Focus on Gastrointestinal Symptoms

Acronym: PARADE

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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