Eradication of Helicobacter pylori and recurrence of bleeding peptic ulcers
| ISRCTN | ISRCTN33848563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33848563 |
| Secondary identifying numbers | 511003 |
- Submission date
- 10/10/2002
- Registration date
- 10/10/2002
- Last edited
- 22/10/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J J Y Sung
Scientific
Scientific
Department of Medicine & Therapeutics
Prince of Wales Hospital
30 Ngan Shing Street
Sha Tin
-
Hong Kong
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bismuth subcitrate, metronidazole, tetracycline, ranitidine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2002 |
| Completion date | 01/10/2003 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- Hong Kong
- United Kingdom
Study participating centre
Department of Medicine & Therapeutics
Sha Tin
-
Hong Kong
-
Hong Kong
Sponsor information
Hong Kong Health Services Research Fund (Hong Kong)
Research organisation
Research organisation
Health Welfare and Food Bureau
Government Secretariat, HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
| Phone | +852 2973 8288 |
|---|---|
| hsrf@hwfb.gov.hk | |
"ROR" |
https://ror.org/03qh32912 |
Funders
Funder type
Research organisation
Hong Kong Health Services Research Fund (Hong Kong)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
