Assessed the Efficacy and Safety of Compound Bismuth Potassium Citrate Tablets given with Omeprazole in Eradication of H.pylori in Active Duodenal Ulcer Patients.

Multicenter, randomized, blind, active-controlled clinical trial: Assessed the Efficacy and Safety of Compound Bismuth Potassium Citrate Tablets given with Omeprazole in Eradication of H.pylori in Active Duodenal Ulcer Patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003143

Enrollment

Unknown

Registered

2013-02-01

Start date

2013-04-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

duodenal ucler of Helicobacter pylori infection

Interventions

study group:Compound Bismuth Potassium Citrate+Omeprazoleeradicate H.pylori

Control:Omeprazole+Amoxicillin+Bismuth Potassium Citrate+Clarithromycin quadruple eradicate H.pylori

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients were male or female, aged 18 to 65 years inclusively; 2. H.pylori infection was confirmed when both positive result in rapid urease test of a gastric biopsy specimen and 13C-urea bueath test; 3. Active duodenal ulcer(>=3mm and <=15mm) at baseline endoscopy; 4. Mental and legal ability to give a written informed consent.

Exclusion criteria

Exclusion criteria: Previous surgery of the stomach such as partial gastrectomy, gastroplasty,or vagotomy.Patients with simple closure of a perforated ulcer or oversewing of bleeding ulcer may be included; Presence of Esophagus disease(esophageal erosions and ulcers), or gastric urlcer; Pregnancy or lactation, or women of childbearing potential not using reliable contraception (i.e.Oophorectomy, hysterectomy, tubal ligation for at least 6 months, oral contraceptive, barrier contraceptive).

Design outcomes

Primary

Measure	Time frame
eradication rate;	—

Countries

hina

Contacts

Public ContactNonghua Lv

lunonghua@163.com+86 13707086809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 6, 2026