Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding

The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to treat upper gastrointestinal ulcer bleeding.

Study Overview

• Status: Unknown
• Conditions: Bleeding Gastric Ulcer; Bleeding Duodenal Ulcer
• Intervention / Treatment: Drug: L-pantoprazole sodium; Drug: Panmeilu

• Study Type: Interventional
• Enrollment (Anticipated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Han Ying, doctor; Phone Number: 13991963770; Email: hanying@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • The First Affiliated Hospital of the Fourth Military Medical University
      • Contact: Han Ying, doctor; Phone Number: 13991963770; Email: hanying@fmmu.edu.cn
      • Principal Investigator: Fan Dai ming, doctor
      • Principal Investigator: Wu Kai chun, doctor
      • Sub-Investigator: Han Ying, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 18-65 years, gender:both.
2. Patients whose Forrest classification were in Ⅰ b-Ⅱ c were diagnosed with non-variceal duodenal and / or gastric ulcer bleeding by endoscopy within 24 hours and patients manifested vomiting and / or black stools and other symptoms of upper gastrointestinal bleeding.
3. Patients were diagnosed with upper gastrointestinal bleeding mild to moderate;
4. Informed consent granted.
5. Patients agreed to take medicine and assess.

Exclusion Criteria:

1. Patients were diagnosed with upper gastrointestinal bleeding by endoscopy caused by esophageal varices and portal hypertensive gastropathy, Mallory-Weiss syndrome, dieulafoy disease.
2. Pregnant women or breastfeeding women.
3. Patients who had undergone surgery because of ulcer complications or gastrectomy, gastrointestinal anastomosis within 30 days before the trial.
4. Patients were diagnosed with gastrinoma or gastric malignancy.
5. Patients had other associated complications, which may affect the efficacy.
6. Patients who like alcohol abuse, drug addicts or others which are not suitable for drug trials.
7. Patients who were allergic to any ingredient of any PPI and allergies.
8. Patients diagnosed with small vessel spurting who had to undergo endoscopic hemostasis or surgery or severe gastrointestinal bleeding.
9. Patients suffering from serious heart, brain, lung, liver, kidney disease or severe hypertension.
10. Patients who had coagulopathy, whose PT wasmore three seconds than normal controls, whose APTT> 1.5 times the upper limit of normal or low-dose heparin treatment.
11. Patients whose systolic blood pressure less than 90mmHg or lower > 30mmHg than the baseline systolic blood pressure, pulse pressure less than 20mmHg, hematocrit less than 20%.
12. Patients who participated in other clinical trials within three months before this trial.
13. Patients who need to use other drugs which may affect the trial during the trial or a week before the trial.
14. Patients who were considered unsuitable for selected candidates.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-pantoprazole sodium	Drug: L-pantoprazole sodium; 2 injection L-pantoprazole sodium (40mg), Bid
Active Comparator: Panmeilu	Drug: Panmeilu; An injection Panmeilu (80 mg) + 1 branch placebo, Bid;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemostatic success rate	6 days

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Hemorrhage; Stomach Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: 2014-CTTQ-SPAN