Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

NCT02776371 | Completed Phase 4 DMC

• 1 other identifier: 2016SDU-QILU-05
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.

Conditions

Helicobacter Pylori Eradication Rate

Keywords

Helicobacter pylori; Sequential therapy; Modified non-clarithromycin triple therapy

Outcome Measures

Primary Outcomes (1)

• the difference of eradication rates between 2 groups

  5 months

Secondary Outcomes (1)

• the different rates of adverse events between 2 groups

  5 months

Study Arms (2)

Modified non-clarithromycin triple therapy

EXPERIMENTAL

H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Drug: Modified non-clarithromycin triple therapy

Sequential therapy

ACTIVE COMPARATOR

H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Drug: Sequential therapy

Interventions

Modified non-clarithromycin triple therapy DRUG

H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Modified non-clarithromycin triple therapy

Sequential therapy DRUG

H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Sequential therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.

You may not qualify if:

• negative in rapid urease test (RUT)
• previous standard eradication therapy for H. pylori;
• history of esophagectomy or gastrectomy;
• gastrointestinal malignancy;
• contraindications or allergic to study drugs;
• user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
• cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
• pregnant or lactating women;
• participants of other trial within the past 3 months;
• unwilling or unable to participate in the study.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

• Li Yanqing, MD, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 18, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

CN (1)