Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
The combination of rabeprazole, amoxicillin, and clarithromycin (often abbreviated as RAC) is a triple therapy regimen primarily used for the eradication of Helicobacter pylori (H. pylori) infection, which is associated with peptic ulcers and other gastrointestinal conditions. ## Composition and Mechanism This triple therapy combines three distinct medications: 1. **Rabeprazole**: A proton pump inhibitor (PPI) that decreases stomach acid production by inhibiting the gastric H+,K+ ATPase enzyme (proton pump) at the secretory surface of gastric parietal cells[3][5]. 2. **Amoxicillin**: A bactericidal antibiotic similar to penicillin that inhibits cell wall biosynthesis in susceptible bacteria during active multiplication, leading to bacterial death[2]. 3. **Clarithromycin**: A macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S subunit of the bacterial ribosome and preventing translocation[2][6]. ## Clinical Efficacy Studies have shown this combination to be highly effective for H. pylori eradication: - A standard 7-day regimen has demonstrated an average eradication rate of 87.2%[1]. - Some studies have found that a 7-day regimen is just as effective as a 10-day regimen, with no significant advantage to the longer duration[1]. - A pilot study of a shortened 4-day triple therapy with this combination achieved a 90% eradication rate, comparable to established 7-day regimens[8]. ## Administration The typical administration is twice daily for 7 days, though in cases of severity, treatment may be extended to 14 days[2]. The medications are often packaged together in dosing cards to facilitate proper administration. ## Side Effects Adverse reactions reported with this combination therapy include: - Digestive system: Nausea, vomiting, diarrhea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration[2][5]. - Nervous system: Confusion, headache, dizziness[2]. - Musculoskeletal system: Myalgia[2]. - Skin reactions[2]. - Urogenital system: Vaginitis, vaginal moniliasis[2]. In clinical trials, the most frequently reported drug-related adverse reactions for patients receiving this therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively[5]. ## Indications This combination is specifically indicated for: - Eradication of H. pylori in active chronic gastric and duodenal ulcers[2]. - Treatment and prevention of ulcers associated with H. pylori infection[3]. ## Contraindications The therapy is contraindicated in patients with known hypersensitivity to any of its components[2]. Special care should be taken when administering to elderly patients who may suffer from asymptomatic renal and hepatic dysfunction[2]. ## Drug Interactions Clarithromycin may interact with several medications including theophylline, carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide, and astemizole[2][5]. This triple therapy has proven to be a valuable first-line treatment option for H. pylori infection, with high efficacy rates and a manageable side effect profile.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on Rabeprazole + Amoxicillin + Clarithromycin.