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Polaprezinc combined triple therapy for Helicobacter pylori associated gastritis: a randomized, parallel controlled, multicenter trial

Polaprezinc combined triple therapy for Helicobacter pylori associated gastritis: a randomized, parallel controlled, open-label, multicenter trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16009688
Enrollment
Unknown
Registered
2016-10-29
Start date
2014-01-01
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

Helicobacter pylori associated gastritis

Interventions

Experiment group A:Omeprazole 20mg Bid+amoxicillin 1g Bid+ clarithromycin 0.5g Bid+ polaprezinc 75mg Bid× 2 weeks
Experiment group B:Omeprazole 20mg Bid+amoxicillin 1g Bid+ clarithromycin 0.5g Bid+ polaprezinc 150mg Bid× 2 weeks
Control group:Omeprazole 20mg Bid+amoxicillin 1g Bid+ clarithromycin 0.5g Bid× 2 weeks

Sponsors

Department of Gastroenterology, Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Ages 18-70 years; 2. Positive C13 or C14 urea breath test; 3. Gastroscopy within 6 months to exclude ulcer, gastric cancer etc.; 4. Penicillin skin test negtive; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pre-existing antibiotics or bismuth therapy within 4 weeks before enrollment of the present study; 2. Pre-existing PPI therapy within 2 weeks before enrollment of the present study; 3. Severe liver, heart, kidney disease, alcoholism, malignant and other serious diseases; 4. Psychosis, severe neurosis; 5. Allergy to polaprezinc or penicillin; 6. Pregnant or lactating women; 7. Participation in other clinical trials within 3 months before enrollment of the present study.

Design outcomes

Primary

MeasureTime frame
H.pylori eradication rate;

Secondary

MeasureTime frame
improvement of digestive symptoms including upper abdominal pain, acid reflux, belching, heartburn, bloating, nausea and vomiting;

Countries

China

Contacts

Public ContactJiaming Qian

Department of Gastroenterology, Peking Union Medical College Hospital

qianjiaming1957@126.com+86 13601276395

Outcome results

None listed

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