Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections

NCT01566643 | Unknown Phase 4 DMC

• 2 other identifiers: TCRD100-16IRB099-71
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective controlled randomized open-label clinical trial is designed to determine the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin + metronidazole.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; antibiotic resistance; sequential-concomitant hybrid therapy

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.

  4 weeks after complete use of drug for treatment

Study Arms (3)

Hybrid-10

EXPERIMENTAL

RA3-RACM7: rabeprazole + amoxicillin x 3 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days.

Drug: RA3-RACM7

Hybrid-12

EXPERIMENTAL

RA5-RACM7: rabeprazole + amoxicillin x 5 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days

Drug: RA5-RACM7

Hybrid-14

EXPERIMENTAL

RA7-RACM7: rabeprazole + amoxicillin x 7 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days

Drug: RA7-RACM7

Interventions

RA5-RACM7 DRUG

rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days

Also known as: Pariet x 12 days., Hiconcil x 12 days., Klarid x 7 days., Flagyl x 7 days.

Hybrid-12

RA3-RACM7 DRUG

rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days

Also known as: Pariet x 10 days., Hiconcil x 10 days., Klarid x 7 days., Flagyl x 7 days.

Hybrid-10

RA7-RACM7 DRUG

rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days

Also known as: Pariet x 14 days., Hiconcil x 14 days., Klarid x 7 days., Flagyl x 7 days.

Hybrid-14

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient proved with infection of H. pylori in gastric mucosa (at least two of four tests positive)

You may not qualify if:

• woman in breast feeding or pregnancy.
• allergy to drugs used in study.
• previously treated for H. pylori.
• intolerance to fructose, lactose.
• patients with hematologic, brain or spinal disorders
• patients under 20 years old
• patients under aspirin or clopidogrel
• patients with history of gastric cancer or gastric resection operation.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead
• Kaohsiung Medical University: collaborator

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, 97002, Taiwan

RECRUITING

Study Officials

• Ming-Cheh CHEN, MD

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Cheh CHEN, MD

CONTACT

+886-910-521003; MingCheh_chen@tzuchi.com.tw

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: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

TW (1)