Additional identifiers
EudraCT number
2004-001320-20
ClinicalTrials.gov number
Protocol/serial number
HP-R/2003
Study information
Scientific title
Acronym
Study hypothesis
Rifabutin-based therapy will achieve an eradication rate of Helicobacter infection similar to quadruple therapy as a second-line treatment.
Ethics approval
Approved on 23/04/2004 by "Comité Autonómico de Ensayos Clinicos de Andalucía" and authorised by " Agencia Española de Medicamentos y Productos Sanitarios" with EudraCT ref 2004-001320-20.
Study design
Randomised multicentric open clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Helicobacter pylori infection after failed first treatment
Intervention
Allocated the patients to two options of therapy:
1. Experimental: omeprazol 20 mg/12 hours and amoxicillin 1 gr/12 hours and rifabutin 150 mg/12 hours for seven days
2. Control therapy: omeprazol 20 mg/12 hours and bismuth 120 mg/6 hours and metronidazole 500 mg/8 hours and tetracycline 500 mg/6 hours for seven days
The duration of follow up was 45 days after medications.
Intervention type
Drug
Phase
Not Specified
Drug names
Rifabutin, omeprazole, metranidazole, tetracycline and bismuth
Primary outcome measure
Efficacy assesed by urea breath test, measured 45 days after completion of the treatment.
Secondary outcome measures
Adverse events at the completion of the treatment, and 45 days after the completion of the treatment.
Overall trial start date
01/09/2004
Overall trial end date
01/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients in whom Helicobacter pylori infection persisted after a triple therapy treatment were included.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
206
Participant exclusion criteria
1. Withheld consent
2. Had initially been treated by the "Test and Treat" procedure, or a baseline endoscopy was not obtained
3. Fulfilment of the treatment regimen and attendance at follow-up appointments could not reasonably be expected
4. Human Immunodeficiency Virus (HIV) positive status
5. Active alcoholism
6. Addiction to drugs
7. Age less than 18 years or more than 75 years
8. The suspicion of tuberculous infection
9. Either because of a positive intradermal reaction to Mantoux and compatible thorax radiography, or if the patient had previously received tuberculostatic treatment, or a known allergy to any of the components of either of the two treatment regimens
10. Received quadruple therapy as first-line treatment, or any other treatment including bismuth (e.g., ranitidine bismuth citrate), or antibiotics during the previous month
11. Severe associated diseases:
a. cardiac insufficiency
b. respiratory insufficiency
c. chronic kidney insufficiency
d. hepatic insufficiency
e. advanced neoplasic diseases
12. Pregnant or lactating
Recruitment start date
01/09/2004
Recruitment end date
01/12/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Unidad de Aparato Digestivo
Marbella
29603
Spain
Sponsor information
Organisation
Andalusian Digestive Disease Society (Sociedad Andaluza de Patología Digestiva) (Spain)
Sponsor details
A7 Km 187 s/n
Marbella
29603
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Andalucia Health Committee (Consejería de Salud de la Junta de Andalucía) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fundación Hospital Costa del Sol de Marbella (Spain)
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17651479
Publication citations
-
Results
Navarro-Jarabo JM, Fernández N, Sousa FL, Cabrera E, Castro M, Ramírez LM, Rivera R, Ubiña E, Vera F, Méndez I, Rivas-Ruiz F, Moreno JL, Perea-Milla E, Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection., BMC Gastroenterol, 2007, 7, 31, doi: 10.1186/1471-230X-7-31.