NCT00926809UnknownPhase 4
Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial
Korean College of Helicobacter and Upper Gastrointestinal Research6 sites in 1 country232 target enrollmentStarted: September 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 232
- Locations
- 6
- Primary Endpoint
- ulcer healing rate by endoscopic assessment
Study Overview
Brief Summary
This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •30 - 75 years old
- •Early gastric cancer (< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (< 3 cm in size)
- •Helicobacter pylori positive
Exclusion Criteria
- •Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
- •History of Helicobacter pylori eradication
- •History of gastric surgery or other cancers
- •Major comorbidities
- •Medication of ASA, NSAIDS, steroids, anti-coagulants
Arms & Interventions
Eradication
Active Comparator
Helicobacter pylori eradication
Intervention: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin (Drug)
No eradication
Placebo Comparator
No eradication for Helicobacter pylori
Intervention: Lansoprazole (proton pump inhibitor), placebo (Drug)
Outcomes
Primary Outcomes
ulcer healing rate by endoscopic assessment
Time Frame: 8 weeks
Secondary Outcomes
- ulcer reduction rate by endoscopic assessment(8 weeks)
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Completed
Phase 4
Treatment of CNS Sarcoidosis With H.P. Acthar GelCNS SarcoidosisNCT02298491University of Maryland, Baltimore4
Unknown
Not Applicable
Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side EffectsNon-steroidal Anti-inflammatory Drug Adverse ReactionNCT01547559Sun Yat-sen University369
Unknown
Not Applicable
Evaluate the Effect of Hyaluronic Acid in the Treatment of Furcation InvolvementFurcation DefectsNCT04851548Riyadh Elm University18
Terminated
Not Applicable
Leech Therapy for Postherpetic NeuralgiaPostherpetic NeuralgiaNCT01744522Universität Duisburg-Essen6
Completed
Phase 2
Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side EffectsPoisoning by BCG VaccineNCT02207608University of Rome Tor Vergata30