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Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

I

Incheon St.Mary's Hospital

Status and phase

Unknown
Phase 4

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Sequential therapy 14 days
Drug: Concomitant therapy 10 days
Drug: Sequential therapy 10 days
Drug: Concomitant therapy 14 days

Study type

Interventional

Funder types

Other

Identifiers

NCT02108184
PSungmin

Details and patient eligibility

About

Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

single center, randomized trial

  1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
  2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
  3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
  4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days

1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance

Enrollment

264 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 20~80 patients
  • agreement of informed consent
  • H.pylori positive (biopsy, CLO)
  • Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer

Exclusion criteria

  • H.pylori eradication history
  • severe hepatic, renal, cardiac failure
  • pregnancy, participant of other study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

264 participants in 4 patient groups

Sequential therapy 10 days
Experimental group
Description:
1.(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 5 days
Treatment:
Drug: Sequential therapy 10 days
Sequential therapy 14 days
Active Comparator group
Description:
(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days
Treatment:
Drug: Sequential therapy 14 days
Concomitant therapy 10 days
Active Comparator group
Description:
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days
Treatment:
Drug: Concomitant therapy 10 days
Concomitant therapy 14 days
Active Comparator group
Description:
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days
Treatment:
Drug: Concomitant therapy 14 days

Trial contacts and locations

1

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Central trial contact

Sung min Park

Data sourced from clinicaltrials.gov

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