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

NCT ID: NCT02108756

Last Updated: 2014-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-06-30

Brief Summary

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

Conditions

Bleeding Gastric Ulcer; Bleeding Duodenal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L-pantoprazole sodium

Group Type: EXPERIMENTAL

L-pantoprazole sodium

Intervention Type: DRUG

2 injection L-pantoprazole sodium (40mg), Bid

Panmeilu

Group Type: ACTIVE_COMPARATOR

Panmeilu

Intervention Type: DRUG

An injection Panmeilu (80 mg) + 1 branch placebo, Bid;

Interventions

L-pantoprazole sodium

2 injection L-pantoprazole sodium (40mg), Bid

Intervention Type: DRUG

Panmeilu

An injection Panmeilu (80 mg) + 1 branch placebo, Bid;

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of the Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Han Ying, doctor

Role: CONTACT

hanying@fmmu.edu.cn

13991963770

Facility Contacts

Han Ying, doctor

Role: primary

hanying@fmmu.edu.cn

13991963770

Other Identifiers

2014-CTTQ-SPAN

Identifier Type: -

Identifier Source: org_study_id