GERDPhase 4NCT02140073
Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
A Phase 4 study testing omeprazole+domperidone SR and omeprazole in people with GERD, run by Belarusian Medical Academy of Post-Graduate Education at 2 sites in Belarus.
Trial summary
The purpose of this study is to determine the efficacy, safety, and tolerability of omeprazole in combination with domperidone in GERD treatment for subsequent efficient pharmacotherapy of GERD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- omeprazole+domperidone SR and omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBelarus
- Study dates
- Dec 2013to Jun 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria of inclusion of subjects
- desire to participate in the trial and ability to sign the informed consent;
- age above 18;
- gastroesophageal reflux disease, manifested in heartburn no less than twice a week prior to the 1st visit;
- use for the trial period of safe contraception methods for women of fertile age;
- results of ultrasonography (US) of abdominal cavity organs (ACO) performed in the last 6 months before the enrollment.
Criteria of non-inclusion refusal to undergo the endoscopic examination;
- gastroesophageal reflux disease with severe esophagitis (grade С or D against the Los Angeles classification);
- Barrett esophagus;
- pregnancy or lactation;
- administration of nonsteroidal antiinflammatory drugs (NSAIDs), aspirin, bisphosphonates, nitrates, calcium antagonists, proton pump inhibitors or Н2-blockers, prokinetics, clopidogrel;
- participation in other clinical trial;
- history of allergic reaction or intolerance of components of medicinal products;
- esophageal stricture;
- gastrectomy or gastric resection;
- malignant neoplasms in any location at present;
- alcohol abuse;
- severe cardiovascular or respiratory insufficiency;
- hepatic insufficiency;
- renal insufficiency.
Criteria of exclusion
- investigator's opinion on the necessity to exclude the patient for their own benefit;
- erroneous enrollment;
- investigator's decision to exclude the patient due to serious deviation from the trial program;
- serious adverse events (SAEs) including death (stating the date of death);
- adverse events (AEs) requiring monitoring and drug therapy;
- acute diseases or conditions which in the investigator's opinion require the patient to be excluded from the trial;
- administration during the trial of NSAIDs, aspirin, bisphosphonates, nitrates, calcium antagonists, proton pump inhibitors or Н2-blockers, prokinetics, antacids (except for the tested MP or the comparator MP) or the necessity for such treatment to be prescribed;
- positive pregnancy test (for women);
- patient's failure to appear for the visit;
- patient's refusal to continue the trial;
- intolerance of the tested MP or the comparator MP;
Trial locations and contacts
2 sites in 1 country.
Belarus2 sites
Gastroenterology and Nutrition Department. Byelorussian Medical Academy Postgraduate Education
Minsk, 220013
Mother and Child National Reaserch Centre
Minsk, 220053
About this study
The purpose of this study is to determine the efficacy, safety, and tolerability of omeprazole in combination with domperidone in GERD treatment for subsequent efficient pharmacotherapy of GERD.
Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the efficiency and advantages of one GERD therapy considering efficacy, safety, and individual variance of patients' reactions
Read the detailed description
Study design . Primary and secondary endpoints
Primary endpoint:
- reduced incidence and severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation.
Secondary endpoints:
- reduced severity of heartburn estimated against visual analog scale after 8 weeks of treatment;
- incidence of events of heartburn after 4 and 8 weeks of treatment;
- proportion of patients with completely jugulated heartburn at the 4th and 8th weeks of treatment;
- number of days without heartburn after 4 weeks of treatment;
- proportion of patients with resolved esophagitis after 8 weeks of treatment in subjects with esophagitis at the time of enrollment.
Safety endpoints:
- incidence of adverse events in the group of patients who received at least one dose of the medicinal product after randomization;
- incidence of serious adverse events;
- incidence of severe adverse events;
- incidence of adverse events definitely caused by administration of the tested medicinal product.
Description of the trial planned By its design the trial will be a randomized open comparative parallel study.
Study flow chart:
Screening=>Randomization=>Group 1(Omez-DSR),Group 2(Omez) =>Treatment=>Monitoring
13.3. Phases of the trial:
- Screening - preliminary selection of subjects according to clinical criteria; signing of informed consent; prescription and conduction of screening procedures; decision on inclusion/exclusion of subject from the trial on the grounds of the results of screening procedures according to inclusion/exclusion criteria.
- Randomization - random distribution of subjects included into the trial into two groups: group 1 - treatment with tested Omez-DSR preparation, group 2 - treatment with the comparator Omez.
- Treatment - patients receive either Omez-DSR preparation or Omez preparation in the prescribed regimen according to the randomization number. Treatment shall be ambulatory; patients shall visit research center through specified periods.
- After the end of treatment patients shall return to their usual lifestyle, but they are monitored to assess the efficacy of the therapy conducted and to record adverse events.
Description of measures allowing reducing the bias factor Randomization Randomization at phase 2 shall be performed using the WinPepi statistical program, option Masking Partial masking shall be used. Assessment of endoscopic examination at week 8 of treatment shall be blinded; the specialist conducting endoscopy shall not know which therapy was used. Statistical analysis shall be performed after coding of subjects; and during analysis it shall not be known which of the groups is receiving Omez-DSR, and which one - Omez.
Description of treatment Medical preparations authorized in the Republic of Belarus shall be used in the trial: Omez-DSR and Omez.
Dosage Dosage shall be performed in accordance with label recommendations of Omez-DSR and Omez preparations. Dose of Omez shall be 2 capsules/day (40 mg of omeprazole). Dose of Omez-DSR shall be 2 capsules/day (40 mg of omeprazole and 60 mg of domperidone).
Regimen Medicinal preparations shall be prescribed after randomization. Group 1 or OM-DP: the subjects from this group shall be supplied the preparation enough for 8 weeks of treatment. Group 2 or OM: the subjects shall be supplied the preparation enough for 8 weeks.
Features of the phases of the trial
Signing of informed consent:Screening, Assessment of inclusion/exclusion criteria:Screening,Randomization Complaints Screening,Randomization,Week 8/End of treatment,Monitoring After 28 days
Past and present history: Screening,Randomization Drug history: Screening,Week 8/End of treatment, Monitoring After 28 days Physical examination: Screening,Randomization,Week 8/End of treatment, Monitoring After 28 days Height, weight measurement: Screening,Week 8/End of treatment, Monitoring After 28 days Survey against the GERD-Q scale (values of 7 scores): Screening,Week 8/End of treatment Distribution of diaries:Randomization Esophagogastroduodenoscopy: Screening,Week 8/End of treatment Pregnancy test: Screening Distribution of preparation:Randomization Recording of adverse events:Week 8/End of treatment, Monitoring After 28 days Compliance assessment:Week 8/End of treatment
- Conditions
- GERD
- Being tested
- omeprazole+domperidone SR, omeprazole
- Keywords
- GERD, Omez, Omez DSR, heartburn, esophagitis, omeprazole, omeprazole+domperidone
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazole+domperidone SRDrug
Also called Omez DSR
omeprazole 20mg+domperidone SR 30mg, 2 capsules in the morning
omeprazoleDrug
Also called Omez
40mg in the morning
| Study group | Role | What they receive |
|---|---|---|
| omeprazole+domperidone SR | Experimental | patients with GERD receive omeprazole 20mg + domperidone SR 30mg , 2 capsules in the morning Receives: Drug: omeprazole |
| omeprazole | Active comparator | omeprazole 40mg in the morning Receives: Drug: omeprazole+domperidone SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
questionnaire
Measured: change from baseline incidence of heartburn after 8 weeks of treatment
change severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
questionnaire
Measured: change from baseline severity of heartburn at 8 weeks
Secondary outcomes (3)
proportion of patients with completely jugulated heartburn
number of patients with completely jugulated heartburn after 4 weeks of treatment and 8 weeks of treatment
Measured: 4 and 8 weeks of treatment
number of days without heartburn
questionnaire
Measured: 4 weeks of treatment
proportion of patients with resolved esophagitis
based on Esophagogastroduodenoscopy in subjects with esophagitis at the time of enrollment
Measured: after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian Medical Academy of Post-Graduate Education
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Sponsor
- Investigators
- Yury Kh Marakhouski, Professor of Clinical Medicine, Principal investigator, Belarusian Medical Academy of Post-Graduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140073
- Sponsor's protocol ID
- OM2013
- Status last verified
- Mar 2014
- First submitted
- 24 Mar 2014
- Last updated
- 16 May 2014
- Results posted
- No
Publications
Marakhouski KY, Karaseva GA, Ulasivich DN, Marakhouski YK. Omeprazole-Domperidone Fixed Dose Combination vs Omeprazole Monotherapy: A Phase 4, Open-Label, Comparative, Parallel Randomized Controlled Study in Mild to Moderate Gastroesophageal Reflux Disease. Clin Med Insights Gastroenterol. 2017 May 31;10:1179552217709456. doi: 10.1177/1179552217709456. eCollection 2017.
PubMed 28607547
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
- ClinicalTrials.gov ID
- NCT02140073
- Acronym / sponsor ID
- OM2013
- Conditions
- GERD
- Keywords
- GERD, Omez, Omez DSR, heartburn, esophagitis, omeprazole, omeprazole+domperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Belarusian Medical Academy of Post-Graduate EducationUniversity, hospital or other
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 16 May 2014 (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.
The purpose of this study is to determine the efficacy, safety, and tolerability of omeprazole in combination with domperidone in GERD treatment for subsequent efficient pharmacotherapy of GERD.
Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the efficiency and advantages of one GERD therapy considering efficacy, safety, and individual variance of patients' reactions
Detailed description
Study design . Primary and secondary endpoints
Primary endpoint:
- reduced incidence and severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation.
Secondary endpoints:
- reduced severity of heartburn estimated against visual analog scale after 8 weeks of treatment;
- incidence of events of heartburn after 4 and 8 weeks of treatment;
- proportion of patients with completely jugulated heartburn at the 4th and 8th weeks of treatment;
- number of days without heartburn after 4 weeks of treatment;
- proportion of patients with resolved esophagitis after 8 weeks of treatment in subjects with esophagitis at the time of enrollment.
Safety endpoints:
- incidence of adverse events in the group of patients who received at least one dose of the medicinal product after randomization;
- incidence of serious adverse events;
- incidence of severe adverse events;
- incidence of adverse events definitely caused by administration of the tested medicinal product.
Description of the trial planned By its design the trial will be a randomized open comparative parallel study.
Study flow chart:
Screening=>Randomization=>Group 1(Omez-DSR),Group 2(Omez) =>Treatment=>Monitoring
13.3. Phases of the trial:
- Screening - preliminary selection of subjects according to clinical criteria; signing of informed consent; prescription and conduction of screening procedures; decision on inclusion/exclusion of subject from the trial on the grounds of the results of screening procedures according to inclusion/exclusion criteria.
- Randomization - random distribution of subjects included into the trial into two groups: group 1 - treatment with tested Omez-DSR preparation, group 2 - treatment with the comparator Omez.
- Treatment - patients receive either Omez-DSR preparation or Omez preparation in the prescribed regimen according to the randomization number. Treatment shall be ambulatory; patients shall visit research center through specified periods.
- After the end of treatment patients shall return to their usual lifestyle, but they are monitored to assess the efficacy of the therapy conducted and to record adverse events.
Description of measures allowing reducing the bias factor Randomization Randomization at phase 2 shall be performed using the WinPepi statistical program, option Masking Partial masking shall be used. Assessment of endoscopic examination at week 8 of treatment shall be blinded; the specialist conducting endoscopy shall not know which therapy was used. Statistical analysis shall be performed after coding of subjects; and during analysis it shall not be known which of the groups is receiving Omez-DSR, and which one - Omez.
Description of treatment Medical preparations authorized in the Republic of Belarus shall be used in the trial: Omez-DSR and Omez.
Dosage Dosage shall be performed in accordance with label recommendations of Omez-DSR and Omez preparations. Dose of Omez shall be 2 capsules/day (40 mg of omeprazole). Dose of Omez-DSR shall be 2 capsules/day (40 mg of omeprazole and 60 mg of domperidone).
Regimen Medicinal preparations shall be prescribed after randomization. Group 1 or OM-DP: the subjects from this group shall be supplied the preparation enough for 8 weeks of treatment. Group 2 or OM: the subjects shall be supplied the preparation enough for 8 weeks.
Features of the phases of the trial
Signing of informed consent:Screening, Assessment of inclusion/exclusion criteria:Screening,Randomization Complaints Screening,Randomization,Week 8/End of treatment,Monitoring After 28 days
Past and present history: Screening,Randomization Drug history: Screening,Week 8/End of treatment, Monitoring After 28 days Physical examination: Screening,Randomization,Week 8/End of treatment, Monitoring After 28 days Height, weight measurement: Screening,Week 8/End of treatment, Monitoring After 28 days Survey against the GERD-Q scale (values of 7 scores): Screening,Week 8/End of treatment Distribution of diaries:Randomization Esophagogastroduodenoscopy: Screening,Week 8/End of treatment Pregnancy test: Screening Distribution of preparation:Randomization Recording of adverse events:Week 8/End of treatment, Monitoring After 28 days Compliance assessment:Week 8/End of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omeprazole+domperidone SR | Experimental | Drug: omeprazolepatients with GERD receive omeprazole 20mg + domperidone SR 30mg , 2 capsules in the morning |
| omeprazole | Active comparator | Drug: omeprazole+domperidone SRomeprazole 40mg in the morning |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| omeprazole+domperidone SRAlso: Omez DSRomeprazole 20mg+domperidone SR 30mg, 2 capsules in the morning | Drug | omeprazole |
| omeprazoleAlso: Omez40mg in the morning | Drug | omeprazole+domperidone SR |
Primary outcome
change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
Time frame: change from baseline incidence of heartburn after 8 weeks of treatment
questionnaire
change severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
Time frame: change from baseline severity of heartburn at 8 weeks
questionnaire
3 secondary outcomes
proportion of patients with completely jugulated heartburn
Time frame: 4 and 8 weeks of treatment
number of days without heartburn
Time frame: 4 weeks of treatment
proportion of patients with resolved esophagitis
Time frame: after 8 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Derived from this study: PubMed 28607547Marakhouski KY, Karaseva GA, Ulasivich DN, Marakhouski YK. Omeprazole-Domperidone Fixed Dose Combination vs Omeprazole Monotherapy: A Phase 4, Open-Label, Comparative, Parallel Randomized Controlled Study in Mild to Moderate Gastroesophageal Reflux Disease. Clin Med Insights Gastroenterol. 2017 May 31;10:1179552217709456. doi: 10.1177/1179552217709456. eCollection 2017.
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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.
Yury Kh Marakhouski, Professor of Clinical Medicine principal investigator
Belarusian Medical Academy of Post-Graduate Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omeprazole+domperidone SR and omeprazole in people with GERD, run by Belarusian Medical Academy of Post-Graduate Education at 2 sites in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation (time frame: change from baseline incidence of heartburn after 8 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140073, which also lists 1 linked publication.
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 16 May 2014.