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A randomized, double-blind, double-dummy, parallel controlled, multicenter trial for levorotolazole sodium enterosols in the treatment of duodenal ulcer

A randomized, double-blind, double-dummy, parallel controlled, multicenter trial for levorotolazole sodium enterosols in the treatment of duodenal ulcer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018635
Enrollment
Unknown
Registered
2018-09-30
Start date
2018-10-03
Completion date
Unknown
Last updated
2018-10-10

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

Conditions

Duodenal ulcer

Interventions

Group 1:levamoprazole sodium enteric-coated tablets
Group 2:Pantoprazole enteric-coated tablets

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) aged 18 to 70 years old male and female; (2) meet the diagnostic criteria for duodenal ulcer; (3) duodenal ulcer was confirmed by gastroscopy in the first week, and Sakita and Miwa ulcer stage was A1 or A2. (4) the number of ulcers is no more than 2, and the maximum diameter is no more than 2.0 cm; (5) drugs for treating peptic ulcer (such as PPIs, h2-ras and gastric mucosa protectant) were not used within 1 week before enrollment; (6) agree to participate in this clinical trial and have signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) have a history of allergy to experimental drugs and their ingredients; (2) patients with cancerous ulcer, zhuo-ai syndrome, esophageal lesions (esophageal erosion, varicose veins or ulcers), gastric fundus stroma, gastric varicose veins, gastric MALT lymphoma or gastric ulcer; (3) history of gastric surgery: partial gastrectomy, gastroplasty, vagus nerve amputation (but patients who have had simple perforation repair for gastric ulcer or ulcer suture for hemostasis can be included); (4) severe complications, such as pyloric obstruction and endoscopic bleeding; (5) patients with other serious digestive tract diseases, such as crohn's disease, ulcerative colitis, etc.; (6) patients with severe liver and kidney diseases, or abnormal liver and kidney function examination (ALT and AST = 1.5 times the normal upper limit and SCr > normal upper limit); (7) severe heart and lung diseases, advanced tumors, blood and hematopoietic system diseases, or other serious or progressive systemic diseases; (8) inability or unwillingness to cooperate due to neurological or mental disorders; (9) suspected or true history of alcohol and drug abuse, or other conditions that, according to the researcher's judgment, have reduced the possibility of enrollment or complicated the enrollment; (10) women during pregnancy and lactation and patients with family planning for the next six months; (11) the investigator considers it inappropriate to participate in the clinical trial; (12) participated in other clinical trials three months before the trial.

Design outcomes

Primary

MeasureTime frame
The healing rate of ulcer was observed under gastroscope;

Secondary

MeasureTime frame
Total effective rate of clinical symptom relief;Major symptoms (upper abdominal pain, antacids) disappearance rate;Duration of major symptoms (upper abdominal pain, antacids);

Countries

China

Contacts

Public ContactSide Liu

Nanfang Hospital, Southern Medical University

liuside2011@163.com+86 020 61641537

Outcome results

None listed

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