GERDPhase 4Omez-RU2013NCT02922699
Efficacy and Saafety of Omez Iin Patients With H.Pylori Associated Diseases
A Phase 4 study testing OMEZ 40 and OMEZ 80 in people with GERD, run by Dr. Reddy's Laboratories Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GERD
- What is being tested?
- OMEZ 40 and OMEZ 80
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes between the ages of 18 and 75 years old, ready to sign informed consent and and agree to follow all requirements of study protocol.
- The patient should be prepared to fill out questionnaires on their own wedge and symptoms.
- Non pregnant, not nursing patient.
- Patients must be either n of stklimaktericheskom period, or surgically sterile, or throughout the study period using contraceptive methods, the reliability of more than 90%. - Contraceptive methods with the reliability of more than 90% of the normal used e of include the cervical cap with spermicide, diaphragm with spermicide, condoms, oral contraceptives, intrauterine devices, acetate HCWs to siprogesterona and levonorgestrel subdermal implants;
Who cannot join
- A history of surgery performed to reduce gastric acid secretion in the stomach or esophagus to operations and / or upper digestive tract.
- The presence of obstructive strictures or esophageal ulcers, varicose veins vehi ie water, esophageal achalasia.
- Barrett's esophagus.
- patients taking other medications for GERD over a period of two weeks or PPIs during the preceding and a following of the month.
- Zollinger-Ellison syndrome .
- Peptic ulcer and 12 duodenal ulcer in acute
Show all 18Show fewer
- erosive gastro.
- Cancer of the stomach or esophagus.
- Coronary heart disease.
- Colic disease.
- Chronic pancreatitis.
- Gallstone disease.
- Pyloric stenosis.
- Regular intake of steroids or any other drugs ulcerogenic, n as an example of NSAIDs.
- Pregnancy, Kor m tion feeding.
- Patients with esophagitis endoscopically established 4 th or higher degree in s reflection (on a modified scale Hetzel-Dent ) .
- Impaired function of average weight of the liver.
- hypersensitivity to the drug: omeprazole and domperidone
About this study
Official title: A Prospective, Randomized, Open-label Comparative Study to Evaluate the Efficacy and Safety of Two First-line H.Pylori Eradication Regimens Including the Omeprazole 40 or 80 mg, Clarithromycin and Amoxicillin.
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.
Read the 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.
- Conditions
- GERD
- Being tested
- OMEZ 40, OMEZ 80
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMEZ 40Drug
Also called OMEPRAZOLE 40MG
Omez 40 given to patients for 58days along with Amoxicilin and Clarithromycin
OMEZ 80Drug
Also called OMEPRAZOLE 80 MG
Omez 80 patients for 58days along with Amoxicilin and Clarithromycin
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole 40mg | Experimental | Omez 40mg OD Receives: Drug: OMEZ 40 |
| Omeprazole 80 mg | Active comparator | Omez 80mg OD Receives: Drug: OMEZ 80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
H Pylori eradicaion rates
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- V.D Pasechnikov, MD, Principal investigator, Stavropol State Medical University1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922699
- Sponsor's protocol ID
- DRL _ RUS / PMS / 201 2 / OMEZ
- Acronym
- Omez-RU2013
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label Comparative Study to Evaluate the Efficacy and Safety of Two First-line H.Pylori Eradication Regimens Including the Omeprazole 40 or 80 mg, Clarithromycin and Amoxicillin.
- ClinicalTrials.gov ID
- NCT02922699
- Acronym / sponsor ID
- Omez-RU2013 / DRL _ RUS / PMS / 201 2 / OMEZ
- Conditions
- GERD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole 40mg | Experimental | Drug: OMEZ 40Omez 40mg OD |
| Omeprazole 80 mg | Active comparator | Drug: OMEZ 80Omez 80mg OD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes between the ages of 18 and 75 years old, ready to sign informed consent and and agree to follow all requirements of study protocol.
- The patient should be prepared to fill out questionnaires on their own wedge and symptoms.
- Non pregnant, not nursing patient.
- Patients must be either n of stklimaktericheskom period, or surgically sterile, or throughout the study period using contraceptive methods, the reliability of more than 90%. - Contraceptive methods with the reliability of more than 90% of the normal used e of include the cervical cap with spermicide, diaphragm with spermicide, condoms, oral contraceptives, intrauterine devices, acetate HCWs to siprogesterona and levonorgestrel subdermal implants;
Key exclusion criteria (18 listed)
- A history of surgery performed to reduce gastric acid secretion in the stomach or esophagus to operations and / or upper digestive tract.
- The presence of obstructive strictures or esophageal ulcers, varicose veins vehi ie water, esophageal achalasia.
- Barrett's esophagus.
- patients taking other medications for GERD over a period of two weeks or PPIs during the preceding and a following of the month.
- Zollinger-Ellison syndrome .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMEZ 40Also: OMEPRAZOLE 40MGOmez 40 given to patients for 58days along with Amoxicilin and Clarithromycin | Drug | Omeprazole 40mg |
| OMEZ 80Also: OMEPRAZOLE 80 MGOmez 80 patients for 58days along with Amoxicilin and Clarithromycin | Drug | Omeprazole 80 mg |
Primary outcome
H Pylori eradicaion rates
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
V.D Pasechnikov, MD principal investigator
Stavropol State Medical University1
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OMEZ 40 and OMEZ 80 in people with GERD, run by Dr. Reddy's Laboratories Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H Pylori eradicaion rates (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.