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Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

NCT01547559 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2014-10-21

No results posted yet for this study

Summary

We aim to evaluate the protective effects of eradication of HP and continue using Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions. We further aim to explore the effect of GGA on small-intestinal mucosal injuries induced by diclofenac sodium in patients with rheumatic diseases who didn't take NSAIDs in the preceding 6 months.

Conditions

  • Non-steroidal Anti-inflammatory Drug Adverse Reaction

Interventions

DRUG

part1:teprenone

Teprenone 50mg tid after meal for Hp negative patients.

DRUG

part1:EAC-T

esomeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily followed by gastric mucosal protective therapy with teprenone 50mg three times daily for 11 weeks

DRUG

part1:EA-EMC-T

esomeprazole 20 mg plus amoxicillin 1 g, twice daily for 5 days, then esomeprazole 20 mg with clarithromycin 500 mg and metronidazole 500 mg, twice daily for another 5 consecutive days) followed by teprenone 50mg three times daily until 12 weeks

DRUG

part1:teprenone

Teprenone 50mg tid after meal for Hp positive patients.

DRUG

part2:GGA group

GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Minhu Chen, MD PHD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2014-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547559 on ClinicalTrials.gov