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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02108756
Recruitment Status : Unknown
Verified April 2014 by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Information provided by (Responsible Party):
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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;

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

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02108756

Contact: Han Ying, doctor 13991963770

China, Shaanxi
The first affiliated hospital of the Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Han Ying, doctor    13991963770   
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

Responsible Party: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd Identifier: NCT02108756     History of Changes
Other Study ID Numbers: 2014-CTTQ-SPAN
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

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