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

• ClinicalTrials.gov Identifier: NCT02108756
• Recruitment Status: Unknown
• First Posted: April 9, 2014
• Last Update Posted: April 9, 2014
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Information provided by (Responsible Party): Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Bleeding Gastric Ulcer; Bleeding Duodenal Ulcer	Drug: L-pantoprazole sodium; Drug: Panmeilu	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: February 2014
• Estimated Primary Completion Date: April 2015
• Estimated Study Completion Date: June 2015

Arms and Interventions

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;

Outcome Measures

Primary Outcome Measures :

1. Hemostatic success rate [ Time Frame: 6 days ]

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Han Ying, doctor; 13991963770; hanying@fmmu.edu.cn

Locations

China, Shaanxi

The first affiliated hospital of the Fourth Military Medical University; Recruiting

Xi'an, Shaanxi, China, 710032

Contact: Han Ying, doctor 13991963770 hanying@fmmu.edu.cn

Principal Investigator: Fan Dai ming, doctor

Principal Investigator: Wu Kai chun, doctor

Sub-Investigator: Han Ying, doctor

Sponsors and Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

More Information

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02108756
• Other Study ID Numbers: 2014-CTTQ-SPAN
• First Posted: April 9, 2014
• Last Update Posted: April 9, 2014
• Last Verified: April 2014

Additional relevant MeSH terms:

Stomach Ulcer; Duodenal Ulcer; Ulcer; Hemorrhage; Pathologic Processes; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pantoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action