Overview

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

Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to treat upper gastrointestinal ulcer bleeding.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Treatments:
Pantoprazole
Criteria
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.