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Completed

NCT Number: NCT00312806

Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Buenos Aires, Argentina

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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:

  • Written informed consent
  • Outpatients of at least 18 years (21 years in Argentina)
  • Patient considered to have GERD symptoms

Main Exclusion Criteria:

  • Acute peptic ulcer and/or ulcer complications
  • Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
  • Intake of proton pump inhibitors during the last 10 days before study start
  • Female patients of childbearing potential not using adequate means of birth control
  • Pregnant or breast-feeding females

Treatment and study plan

Pantoprazole

Drug

Pantoprazole 40 mg o.d.

Primary outcomes

  1. Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™

    Time frame: 8 weeks

Secondary outcomes

  1. Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™

    Time frame: 4 and 8 weeks

  2. Investigator assessment

    Time frame: 4 and 8 weeks

  3. Safety and efficacy

    Time frame: 4 and 8 weeks

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 11, 2006
Registry last updated
May 7, 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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