Clinical trial NCT02541786: Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
Official title: Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: dexlansoprazole MR
rabeprazole
Helicobacter pylori
triple therapy
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 177
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.

Detailed description: Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female aged more than 20 years.
2. H. pylori-infected outpatients
3. Mental and legal ability to give a written informed consent.

Exclusion Criteria:

1. previous H pylori-eradication therapy,
2. ingestion of antibiotics or bismuth within the prior 4 weeks,
3. patients with allergic history to the medications used,
4. patients with previous gastric surgery,
5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
6. pregnant women.

Primary outcomes:
measure: The rate of H.pylori eradication
timeFrame: 6 weeks after finishing study drugs
Secondary outcomes:
measure: Drug Compliance
timeFrame: 6 weeks after finishing study drugs
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: DENG-CHYANG WU, MD, PHD
role: STUDY_CHAIR
References: