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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT02108756
First received: April 7, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Bleeding Gastric Ulcer
Bleeding Duodenal Ulcer
Drug: L-pantoprazole sodium
Drug: Panmeilu

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • Hemostatic success rate [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 272
Study Start Date: February 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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;

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108756

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
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
  More Information

No publications provided

Responsible Party: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02108756     History of Changes
Other Study ID Numbers: 2014-CTTQ-SPAN
Study First Received: April 7, 2014
Last Updated: April 8, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Hemorrhage
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014