Status:
UNKNOWN
Bismuth Based Quadruple Therapy 10 Days in Children
Lead Sponsor:
Queen Fabiola Children's University Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
Helicobacter pylori infection causes chronic gastritis, peptic ulcer disease and is involved in the development of gastric cancer. Current accepted strategies to eliminate the infection in children a...
Eligibility Criteria
Inclusion
- Paediatric subjects aged 6 to 17 years of either gender
- Body weight ≥ 20kg.
- Helicobacter pylori gastritis confirmed by positive histology and culture with antimicrobial susceptibility testing.
- Antral and corpus biopsies must have been taken for histology and culture during an upper GI endoscopy performed for chronic or recurrent pain in the epigastric region with epigastric tenderness at physical examination.
- Subject able to swallow tablets.
- All girls of child-bearing potential must have a negative urine pregnancy test at Visit 1. If sexually active, girls of child-bearing potential and boys whose partner is of child-bearing potential agree to use highly effective method of birth control during the trial.
- In the Investigator's opinion, patient is willing and able to comply with all trial requirements specified in this protocol.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- Subjects (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically older than 11 years of age).
Exclusion
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Have a history of significant renal or hepatic impairment.
- Have an erosive esophagitis or peptic ulcer disease in the gastric or the duodenal mucosa showed during the upper GI endoscopy.
- Have received proton pump inhibitors within 2 weeks prior to first administration of study agent.
- Have received any antimicrobial agent within 4 weeks prior to first administration of study agent.
- Require routine use (≥ 2 times per week) of non-steroidal anti-inflammatory drug (NSAID).
- Are under any immunosuppressive agent.
- Are under oral or IV steroids
- Have a scheduled elective surgery or any procedures requiring general anaesthesia during the trial.
- Have known allergies or a known hypersensitivity to any Study Drugs or their excipients (refer to Study Drugs SmPCs).
- Contraindication for any of the Study Drugs (refer to Study Drugs SmPCs).
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
- Subjects who are participating or have participated in another study with an IMP in the past 12 weeks.
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03299725
Start Date
November 24 2017
End Date
November 1 2019
Last Update
February 15 2018
Active Locations (1)
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1
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium, 1020