Skip to content

Open, multicenter, single-arm clinical study of large dose rabeprazole sodium in the treatment of peptic ulcer bleeding

Open, multicenter, single-arm clinical study of large dose rabeprazole sodium in the treatment of peptic ulcer bleeding

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020352
Enrollment
Unknown
Registered
2018-12-25
Start date
2019-02-15
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peptic ulcer bleeding

Interventions

Case series:(1) 40mg rapeprazole sodium for injection was added into 0.9% sodium chloride injection 100ml, and the infusion was completed within 30min
(2) then the micropump was continuously pumped at a speed of 4mg/h for 72h
(3) the standard dose of rabeprazole sodium for injection: 20mg, bid, intravenous infusion w

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) meet the diagnostic criteria of peptic ulcer bleeding; (2) symptoms of upper gastrointestinal bleeding such as hematemesis and black stool were observed 48 hours before admission; (3) Gastroscope diagnose Forrest within 24 hours classification for Ia, Ib, and IIa, IIb, IIc patients (including Ia ~ IIa patient must precede endoscopic treatment, IIb, IIc patients not forced endoscopic treatment); (4) aged 18 to 65 years old male and female; (5) screening drugs (such as PPIs, h2-ras, etc.) that have not been used in the first week to affect gastric acid secretion; (6) volunteer to take the test and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with upper gastrointestinal bleeding proved by endoscopy to be caused by other causes, such as esophagogastric varices, portal hypertensive gastropathy, esophagocardial mucosal tearing, Dieulafoy(constant diameter artery malformation) disease, etc.;Or with malignant tumor; (2) severe bleeding requiring surgical treatment, or bleeding accompanied by signs of shock; (3) patients who underwent surgery or underwent gastrectomy, gastrointestinal anastomosis and vagotomy due to ulcer complications within 30 days before the test; (4) abnormal coagulation function; (5) patients with severe anemia (Hb normal upper limit of 1.5 times); (7) those who are allergic or allergic to multiple drugs and those who are allergic to the ingredients of the test drugs; (8) patients with mental illness or dementia;Alcohol dependence or a history of drug abuse; (9) patients with severe hypertension (systolic blood pressure greater than 160mmHg, diastolic blood pressure > 90mmHg) or hypotension (resting sitting blood pressure) < 90/50mmhg; (10) women who are pregnant or breast-feeding and who are ready to give birth during the period of taking medicine or within 3 months after stopping the medicine; (11) those who have participated in clinical trials of other drugs in the past 3 months; (12) the researcher considers that others should not participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Effective hemostasis rate under endoscopy in 72h;

Secondary

MeasureTime frame
(1) the rate of re-endoscopic diagnosis and treatment and surgical operation caused by bleeding within 120h;(2) blood transfusion within 120h;

Countries

China

Contacts

Public ContactLu Chuanglin

Shenzhen Liancheng Pharmaceutical co., LTD

luchuanglin@changao.com+86 13590468136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026