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

NCT00279123 | Completed Phase 4

• 1 other identifier: PPI Trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peptic Ulcer Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate within 30 days after endoscopic therapy

Secondary Outcomes (6)

• Transfusion requirement

• duration of hospital stay

• need for operative intervention

• mortality rate

• gastric pH

Interventions

pantoprazole infusion DRUG

pantoprazole bolus DRUG

no treatment DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kwong Wah Hospital: lead

Study Sites (1)

Department of Surgery, Kwong Wah Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Wai-ka Hung, MBBS

  Department of Surgery, Kowng Wah Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: January 1, 2002
• Last Updated: January 19, 2006

Record last verified: 2006-01

Locations

CN (1)