Efficacy and Saafety of Omez Iin Patients With H.Pylori Associated Diseases
Condition: GERD
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of efficacy of H.pylori eradication during first line therapy using standard or
      high doses of omeprazole administered twice daily in combination with amoxicillin and
      clarithromycin for 10 days.
    

Detailed description: 
      Rationale for the use of high doses of omeprozo la - 80 mg in the scheme of eradication
      therapy 1st line Intensive study of the microorganism Helicobacter pylori (H. pylori) Prodo l
      zhaetsya more than 30 years. Actively study the role of infection in the development and
      maintenance of chronic inflammation of the digestive system and especially its capabilities
      and elimin tion. In 1997, the first recommendations concerning diagnosis and were developed n
      infection, Helicobacter therapy indications for various embodiments and treatment of diseases
      associated with H. pylori. These guidelines are called "first the Maastricht Treaty", or
      Maastricht-1 - the main document Regla and tail by the tactics of patients with H.
      pylori-associated ill and tions. In the future, in connection with obtaining new data on the
      properties of the causative agent, spreading disease, which occurs in H. pylori plays a
      pathogen is, genetically role, and the appearance of information on the effectiveness of
      different eras schemes and dikatsionnoy therapy recommendations were renegotiated, received
      sootvets t tively name Maastricht 2 (2000), and Maastricht-3 (2005). As antihelikoba to puter
      first line therapy authors agreement offer a combination of a proton pump inhibitor (or
      ranitidine bismuth citrate) in the standard dosage (OMe n Rasoli 20mg Lansoprazole 30 mg
      Pantoprazole 40 mg Rabeprazole 20 mg esomeprazole 20 mg) twice a day, in combination with
      clarithromycin (R) 500 mg twice daily and amoxicillin (a) 1000 mg twice a day or
      metronidazole (M) 500 mg twice a day for at least 7 days.

      Under the conditions commonly konstatiruemogo progressive growth of a microorganism
      resistance to most commonly used antibiotics, that it and nuemo reduces the efficiency of
      eradication (data along with 80-90% to 30-60% and even up to 12,5-18,3%) dictated the
      development of new recommendations for Dr. s processing of highly efficient schemes of
      eradication therapy [1, 2].

      The recommendations of the last convocation of experts presented at the XXIV International
      with e nar on the role of Helicobacter and related bacteria in the development of chronic e
      tion of inflammation of the digestive tract and stomach cancer (Symposium "Maastricht-4" on
      13 September 2011, Dublin, Ireland) [3] .

      The methods of increasing the effectiveness of eradication therapy, according to this claim
      about the recent agreement includes the use of high (4-fold) doses of PPI, SW e crease the
      duration of therapy to 10-14 days (increases the effectiveness of treatment at 5%), the use
      of probiotics and prebiotics as adjuvant therapy [3, 4, 5,6].

      Increasing doses of PPIs increases the concentration of drug in the blood, and consequently s
      but increases the antisecretory effect. When using high doses of drugs of this group in the
      eradication schemes, serious side effects have not time in h penetrate due to a short course
      of taking the drugs [7].

      The present study is designed to investigate the efficacy and bezop with of high doses of
      PPIs in the schemes of eradication in terms of Maximal s tion efficiency of therapy of H.
      pylori.
    

Intervention name(s): OMEZ 40; OMEZ 80
Intervention type(s): Drug; Drug
Intervention description(s): Omez 40 given to patients for 58days along with Amoxicilin and Clarithromycin; Omez 80 patients for 58days along with Amoxicilin and Clarithromycin
Other intervention name(s): OMEPRAZOLE 40MG; OMEPRAZOLE 80 MG
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment