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

Primary Purpose

Bleeding Gastric Ulcer, Bleeding Duodenal Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
L-pantoprazole sodium
Panmeilu
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Gastric Ulcer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The first affiliated hospital of the Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-pantoprazole sodium

Panmeilu

Arm Description

Outcomes

Primary Outcome Measures

Hemostatic success rate

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
April 8, 2014
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02108756
Brief Title
Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Gastric Ulcer, Bleeding Duodenal Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-pantoprazole sodium
Arm Type
Experimental
Arm Title
Panmeilu
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
L-pantoprazole sodium
Intervention Description
2 injection L-pantoprazole sodium (40mg), Bid
Intervention Type
Drug
Intervention Name(s)
Panmeilu
Intervention Description
An injection Panmeilu (80 mg) + 1 branch placebo, Bid;
Primary Outcome Measure Information:
Title
Hemostatic success rate
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-65 years, gender:both. 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. Patients were diagnosed with upper gastrointestinal bleeding mild to moderate; Informed consent granted. Patients agreed to take medicine and assess. Exclusion Criteria: Patients were diagnosed with upper gastrointestinal bleeding by endoscopy caused by esophageal varices and portal hypertensive gastropathy, Mallory-Weiss syndrome, dieulafoy disease. Pregnant women or breastfeeding women. Patients who had undergone surgery because of ulcer complications or gastrectomy, gastrointestinal anastomosis within 30 days before the trial. Patients were diagnosed with gastrinoma or gastric malignancy. Patients had other associated complications, which may affect the efficacy. Patients who like alcohol abuse, drug addicts or others which are not suitable for drug trials. Patients who were allergic to any ingredient of any PPI and allergies. Patients diagnosed with small vessel spurting who had to undergo endoscopic hemostasis or surgery or severe gastrointestinal bleeding. Patients suffering from serious heart, brain, lung, liver, kidney disease or severe hypertension. 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. 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%. Patients who participated in other clinical trials within three months before this trial. Patients who need to use other drugs which may affect the trial during the trial or a week before the trial. Patients who were considered unsuitable for selected candidates.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Ying, doctor
Phone
13991963770
Email
hanying@fmmu.edu.cn
Facility Information:
Facility Name
The first affiliated hospital of the Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Ying, doctor
Phone
13991963770
Email
hanying@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Fan Dai ming, doctor
First Name & Middle Initial & Last Name & Degree
Wu Kai chun, doctor
First Name & Middle Initial & Last Name & Degree
Han Ying, doctor

12. IPD Sharing Statement

Learn more about this trial

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

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