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OpenTrials
Completed

NCT Number: NCT00279123

Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers

Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.

There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.

This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.

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Key information

Conditions

Peptic Ulcer Hemorrhage Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, Kwong Wah Hospital

Hong Kong, China

Who can participate

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

Inclusion criteria

  • patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.

Exclusion criteria

  • previous gastrectomy and vagotomy
  • patient taking warfarin
  • intake of anti-secretory drugs in the previous 48 hours

Treatment and study plan

pantoprazole infusion

Drug

pantoprazole bolus

Drug

no treatment

Drug

Primary outcomes

  1. Rebleeding rate within 30 days after endoscopic therapy

Secondary outcomes

  1. Transfusion requirement

  2. duration of hospital stay

  3. need for operative intervention

  4. mortality rate

  5. gastric pH

  6. side effects of pantoprazole

Sponsors and collaborators

Lead sponsor

Kwong Wah Hospital

Other

Registry information

Important dates

Study start
2002
First posted
Jan 19, 2006
Registry last updated
Jan 19, 2006

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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