Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
511003
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Recurrence of bleeding peptic ulcers
Intervention
Added as of 09/11/2009: Please note that this trial did not start as similar studies were carried out by other research groups.
Interventions:
Patients were randomised to receive:
1. Either a one week course of triple therapy with bismuth subcitrate, metronidazole, and tetracycline plus ranitidine, or
2. A six week course of ranitidine 300 mg/day.
After the ulcers healed, the antibiotic-treated patients were not given any medication whereas the ranitidine-treated patients continued to receive a maintenance dose of ranitidine 150 mg/day.
Intervention type
Drug
Phase
Not Specified
Drug names
Bismuth subcitrate, metronidazole, tetracycline, ranitidine
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2002
Overall trial end date
01/10/2003
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Patients over the age of 16
2. Confirmed bleeding from either Duodenal (DU) or Gastric (GU) ulcers with or without stigmata of recent haemorrhage
3. A positive rapid urease test
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
01/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine & Therapeutics
Sha Tin
-
Hong Kong
Sponsor information
Organisation
Hong Kong Health Services Research Fund (Hong Kong)
Sponsor details
Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
+852 2973 8288
hsrf@hwfb.gov.hk
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Hong Kong Health Services Research Fund (Hong Kong)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
No publication intended as of 06/11/2009