Bleeding Gastric UlcerNCT02108756
Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding
A study testing L-pantoprazole sodium and Panmeilu in people with Bleeding Gastric Ulcer and Bleeding Duodenal Ulcer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to treat upper gastrointestinal ulcer bleeding. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bleeding Gastric Ulcer, Bleeding Duodenal Ulcer
- What is being tested?
- L-pantoprazole sodium and Panmeilu
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of the Fourth Military Medical University
Xi'an, Shaanxi, 710032
Han Ying, doctor, 13991963770, hanying@fmmu.edu.cn
Fan Dai ming, doctor
About this study
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
- Being tested
- L-pantoprazole sodium, Panmeilu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-pantoprazole sodiumDrug
2 injection L-pantoprazole sodium (40mg), Bid
PanmeiluDrug
An injection Panmeilu (80 mg) + 1 branch placebo, Bid;
| Study group | Role | What they receive |
|---|---|---|
| L-pantoprazole sodium | Experimental | Not described Receives: Drug: L-pantoprazole sodium |
| Panmeilu | Active comparator | Not described Receives: Drug: Panmeilu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic success rate
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding Gastric UlcerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108756
- Sponsor's protocol ID
- 2014-CTTQ-SPAN
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT02108756
- Acronym / sponsor ID
- 2014-CTTQ-SPAN
- Conditions
- Bleeding Gastric Ulcer, Bleeding Duodenal Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to treat upper gastrointestinal ulcer bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-pantoprazole sodium | Experimental | Drug: L-pantoprazole sodium |
| Panmeilu | Active comparator | Drug: Panmeilu |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-pantoprazole sodium2 injection L-pantoprazole sodium (40mg), Bid | Drug | L-pantoprazole sodium |
| PanmeiluAn injection Panmeilu (80 mg) + 1 branch placebo, Bid; | Drug | Panmeilu |
Primary outcome
Hemostatic success rate
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-pantoprazole sodium and Panmeilu in people with Bleeding Gastric Ulcer and Bleeding Duodenal Ulcer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Ying, doctor (13991963770, hanying@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic success rate (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.