Condition category
Digestive System
Date applied
10/10/2002
Date assigned
10/10/2002
Last edited
22/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J J Y Sung

ORCID ID

Contact details

Department of Medicine & Therapeutics
Prince of Wales Hospital
30 Ngan Shing Street
Sha Tin
-
Hong Kong

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

Publication citations

Additional files

Editorial Notes