Gastroesophageal RefluxPhase 3NCT01493089
Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
A Phase 3 study testing Zegerid and Losec in people with Gastroesophageal Reflux, run by Norgine at 1 site in Poland.
Trial summary
Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied by acid regurgitation and other symptoms, has a substantial negative impact on a patients' quality of life. Although a number of treatment options are available, a more effective therapy is still required. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Zegerid and Losec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2011to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Study patients will be included in the study if they satisfy the following criteria:
- Male or female, between 18 and 75 years old.
- History of frequent episodes of heartburn associated with GERD for at least 2 3 days per week during 2-4 weeks before screening and have responded to standard PPI therapy in the past 12 months.
- Have not taken on-demand PPI therapy for > 3 consecutive days within 4 weeks before the screening period.
- The patient's written informed consent must be obtained prior to inclusion.
- Willing and able to complete the entire procedure and to comply with study instructions.
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- Females of childbearing potential must employ an adequate method of birth control.
- Recorded at least 1 evaluable episode of heartburn on 2 separate days at level 4 or higher on the 9-point Likert severity scale (point 3 on a 0-8 point scale) prior to randomisation.
- Competent in the use and completion of the e-diary.
Who cannot join
- Study patients will be excluded if they meet any of the following criteria:
- Age < 18 or > 75 years old.
- Intake of any medication for the purpose of the eradication of Helicobacter pylori (H. pylori) during the last 28 days before the start of the study.
- Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (≥ 3 consecutive days per week) during the last 28 days before the start of the study; except regular intake of enteric coated aspirin dosages up to 150 mg/d.
- Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (excluding: appendectomy, cholecystectomy and polypectomy).
- History of co-existing disease that affects the oesophagus (e.g. Barrett's oesophagus, Zollinger-Ellison syndrome, oesophageal stricture), and have undergone an endoscopy with results of incomplete healing of erosions following standard PPI therapy within the last 3 months.
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- History of active gastric or duodenal ulcers within 3 months of the first dose of the study drug or had acute upper gastrointestinal (GI) bleeding within last 6 months.
- Documented presence of severe renal or hepatic insufficiency.
- Known hypersensitivity to omeprazole.
- Concurrent participation in a study with an investigational drug or participation within 30 days of study entry.
- Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control.
- Clinically significant laboratory abnormality or disease which, in the opinion of the Investigator, will create a risk for the patient, obscure the effects of study treatment or interfere with study results.
- Received or require any of the following drugs within 2 weeks before the first dose of study or continue to need these drugs for concurrent therapy: theophylline, bismuth salts, warfarin, phenytoin, tacrolimus, diazepam, cyclosporine, disulfiram, benzodiazepines, barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate, clopidogrel or protease inhibitors.
- Taking concomitant medications that rely on the presence of gastric acid for optimal bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
- Onset of psychoactive medication (e.g. depressants, stimulants or hallucinogens) in the previous 6 months and during the entire course of the study.
- Recorded < 1 episode of heartburn on 2 separate days at level 4 on the 9 point Likert severity scale (point 3 on a 0-8 point scale) during the 7 day screening period prior to randomisation
- Completing < 90% (< 9 out of 10) of the time points with evaluable data on the e diary.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Gastroenterology and Hepatology, Oncology Centre, Roentgena
Warsaw, 02-781
About this study
Official title: A Phase III, Multi-centre, Double-blind, Double-dummy, Randomised, Study to Assess the Superiority of Zegerid® 20 mg vs. Losec® 20 mg in the Rapid Relief of Heartburn Associated With GERD as on Demand Therapy
Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied by acid regurgitation and other symptoms, has a substantial negative impact on a patients' quality of life. Although a number of treatment options are available, a more effective therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD using an immediate-release omeprazole/sodium bicarbonate formulation when compared with delayed-release omeprazole (Losec®).
- Conditions
- Gastroesophageal Reflux
- Being tested
- Zegerid, Losec
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZegeridDrug
20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
LosecDrug
20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Zegerid | Experimental | Treatment of heartburn with Zegerid Receives: Drug: Zegerid |
| Losec | Active comparator | Treatment of heartburn with Losec Receives: Drug: Losec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient
Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more
Measured: up to 14 days following treatment
Secondary outcomes (5)
Median Time to Sustained Partial Response
Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more
Measured: up to 14 days
Median Time to Sustained Total Relief
Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more
Measured: 14 days
Percentage of Patients Responding in 45 Minutes
percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes
Measured: up to 14 days
Percentage of Patients Responding in 60 Minutes
Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes
Measured: 14 days
Percentage of Patients Responding in 90 Minutes
Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J Regula, MD, Principal investigator, Dept of Gastroenterology and Hepatology, Roentgena, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493089
- Sponsor's protocol ID
- ZEG-01/2010 (GERD)
- Status last verified
- Aug 2013
- First submitted
- 13 Dec 2011
- Last updated
- 13 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Walker D, Ng Kwet Shing R, Jones D, Gruss HJ, Regula J. Challenges of correlating pH change with relief of clinical symptoms in gastro esophageal reflux disease: a phase III, randomized study of Zegerid versus Losec. PLoS One. 2015 Feb 23;10(2):e0116308. doi: 10.1371/journal.pone.0116308. eCollection 2015.
PubMed 25706883
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-centre, Double-blind, Double-dummy, Randomised, Study to Assess the Superiority of Zegerid® 20 mg vs. Losec® 20 mg in the Rapid Relief of Heartburn Associated With GERD as on Demand Therapy
- ClinicalTrials.gov ID
- NCT01493089
- Acronym / sponsor ID
- ZEG-01/2010 (GERD)
- Conditions
- Gastroesophageal Reflux
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Posted 13 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied by acid regurgitation and other symptoms, has a substantial negative impact on a patients' quality of life. Although a number of treatment options are available, a more effective therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD using an immediate-release omeprazole/sodium bicarbonate formulation when compared with delayed-release omeprazole (Losec®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zegerid | Experimental | Drug: ZegeridTreatment of heartburn with Zegerid |
| Losec | Active comparator | Drug: LosecTreatment of heartburn with Losec |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, between 18 and 75 years old.
- History of frequent episodes of heartburn associated with GERD for at least 2 3 days per week during 2-4 weeks before screening and have responded to standard PPI therapy in the past 12 months.
- Have not taken on-demand PPI therapy for > 3 consecutive days within 4 weeks before the screening period.
- The patient's written informed consent must be obtained prior to inclusion.
- Willing and able to complete the entire procedure and to comply with study instructions.
Key exclusion criteria (17 listed)
- Age < 18 or > 75 years old.
- Intake of any medication for the purpose of the eradication of Helicobacter pylori (H. pylori) during the last 28 days before the start of the study.
- Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (≥ 3 consecutive days per week) during the last 28 days before the start of the study; except regular intake of enteric coated aspirin dosages up to 150 mg/d.
- Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (excluding: appendectomy, cholecystectomy and polypectomy).
- History of co-existing disease that affects the oesophagus (e.g. Barrett's oesophagus, Zollinger-Ellison syndrome, oesophageal stricture), and have undergone an endoscopy with results of incomplete healing of erosions following standard PPI therapy within the last 3 months.
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 |
|---|---|---|
| Zegerid20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. | Drug | Zegerid |
| Losec20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. | Drug | Losec |
Primary outcome
Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient
Time frame: up to 14 days following treatment
Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more
5 secondary outcomes
Median Time to Sustained Partial Response
Time frame: up to 14 days
Median Time to Sustained Total Relief
Time frame: 14 days
Percentage of Patients Responding in 45 Minutes
Time frame: up to 14 days
Percentage of Patients Responding in 60 Minutes
Time frame: 14 days
Percentage of Patients Responding in 90 Minutes
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25706883Walker D, Ng Kwet Shing R, Jones D, Gruss HJ, Regula J. Challenges of correlating pH change with relief of clinical symptoms in gastro esophageal reflux disease: a phase III, randomized study of Zegerid versus Losec. PLoS One. 2015 Feb 23;10(2):e0116308. doi: 10.1371/journal.pone.0116308. eCollection 2015.
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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.
J Regula, MD principal investigator
Dept of Gastroenterology and Hepatology, Roentgena, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zegerid and Losec in people with Gastroesophageal Reflux, run by Norgine at 1 site in Poland.
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 9 inclusion and 17 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 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient (time frame: up to 14 days following treatment). 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 NCT01493089, 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 13 Aug 2013.