The goal of this trial is to confirm that eradication rates obtained with Pylera are compatible to those obtained with the current European gols standard, OAC 7 days. This trial will constitute a pivotal trial leading eventually to approval of…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Eradication rate, defined as two negative C-13 urea breath tests performed at 6
and 10 weeks following initiation of therapy.
Secondary outcome
1.
To compare eradication outcomes in patients with presence/past history of
peptic ulcers at baseline vs those without.
2.
To evaluate the effect of resistance of Helicobacter pylori to metronidazole
and clarithromycin on the efficacy of these treatments.
3.
To evaluate the rate of secondary resistance induced by these treatments.
4.
To assess the safety and tolerability of these therapeutic regimens with
respect to subject-reported and investigator-observed adverse events, clinical
laboratory abnormalities and plasma bismuth (Bi) concentrations.
5.
To evaluate compliance to treatment.
Background summary
In order to apply for authorization to market Pylera in European countries,
there is a need to conduct a clinical trial comparing OBMT vs the recognized
gold standard in Europe, OAC given for 7 days. It is hypothesized that OBMT
given for 10 days will be comparable to OAC in terms of eradication rate.
Therefore, a non-inferiority trial design was chosen.
In addition, the aim of this trial will be to further characterize the efficacy
of OBMT vs OAC in bacteria strains identified as being resistant to
metronidazole. Therefore, samples will be collected in order to compare
eradication rates in sensitive vs resistant strains of bacteria.
Considering that bismuth salts are not commonly used in certain European
countries, measuring bismuth plasma levels following treatment with OBMT will
be required to confirm that they stay well below the toxic levels of 50 ug/L.
Study objective
The goal of this trial is to confirm that eradication rates obtained with
Pylera are compatible to those obtained with the current European gols
standard, OAC 7 days. This trial will constitute a pivotal trial leading
eventually to approval of Pylera in European countries.
Study design
Multicenter, multinational, randomized, parallel group, active-controlled,
open-label (but evaluator-blinded) non-inferiority trial.
Intervention
Patients with Helicobacter pylori positive status and upper gastro-intestinal
symptoms will be randomly assigned to a 10-day course of OBMT using a
single-triple capsule containing each bismuth subcitrate potassium (equivalent
to Bi2O3) (B) 40 mg, metronidazole (M) 125 mg, and tetracycline (T) 125 mg
given as 3 capsules qid with omeprazole (O) 20 mg bid or to a 7-day course of
OAC, omeprazole 20 mg plus amoxicillin (A) 1g plus clarithromycin (C) 500 mg,
all bid. Eradication will be confirmed by two negative urea breath tests, at 6
weeks and 10 weeks following treatment onset
Study burden and risks
During the study a maximum of 3 venous blood samples of 30 ml will be taken
from a vein. This can cause some discomfort.
All patients will have to undergo at least 1, and maximum 2 gastroscopic
assessments (in case the Helicobacter pylori was not eradicated). Transient
complaints of sore throat, nausea, gagging, a discomfortable feeling or pain in
the stomach may occur. Serious complications are rare; perforation occurs
approximately in 1:20,000 procedures.
Risks regarding the medication: During previous North American studies with
both treatments, complaints of the GI tract such as diarrhoea, indigestion,
stomach ache and nausea were reported most frequent.
597 Boul. Laurier
Mont St_Hilaire, Qc, J3H 6C4
Canada
597 Boul. Laurier
Mont St_Hilaire, Qc, J3H 6C4
Canada
Listed location countries
Age
Inclusion criteria
-Male or non-pregnant, non-nursing female, 18 years of age and older
-Positive for Helicobacter pylori by both C-13 UBT and at least two of three positive results among rapid urease test, histologic examination and/or culture
-Presence of upper gastrointestinal symptoms
Exclusion criteria
-Previous surgery of the upper gastrointestinal tract (except appendectomy, polypectomy, or cholecystectomy)
-Any current or recent (within 1 month of screening) hematemesis, melena, or documented gastrointestinal bleeding or iron-deficiency anaemia of clinical significance
-Barrett*s esophagus or high-grade dysplasia
-Dysphagia or vomiting as major symptoms
-Previous attempt by a recognized antibiotic treatment to eradicate an adequately documented infection by Helicobacter pylori.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006280-78-NL |
| CCMO | NL21853.078.08 |