Eradication of Helicobacter pylori and recurrence of bleeding peptic ulcers
| ISRCTN | ISRCTN33848563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33848563 |
| Protocol serial number | 511003 |
| Sponsor | Hong Kong Health Services Research Fund (Hong Kong) |
| Funder | Hong Kong Health Services Research Fund (Hong Kong) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bismuth subcitrate, metronidazole, tetracycline, ranitidine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2003 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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
- United Kingdom
- Hong Kong
Study participating centre
Department of Medicine & Therapeutics
Sha Tin
-
Hong Kong
-
Hong Kong
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
