Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
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ClinicalTrials.gov Identifier: NCT01493089 |
Recruitment Status :
Completed
First Posted : December 15, 2011
Results First Posted : August 13, 2013
Last Update Posted : August 13, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux | Drug: Zegerid Drug: Losec | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 239 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Zegerid
Treatment of heartburn with Zegerid
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Drug: Zegerid
20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. |
Active Comparator: Losec
Treatment of heartburn with Losec
|
Drug: Losec
20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. |
- 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
- Median Time to Sustained Partial Response [ Time Frame: up to 14 days ]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
- Median Time to Sustained Total Relief [ Time Frame: 14 days ]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
- Percentage of Patients Responding in 45 Minutes [ Time Frame: up to 14 days ]percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes
- Percentage of Patients Responding in 60 Minutes [ Time Frame: 14 days ]Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes
- Percentage of Patients Responding in 90 Minutes [ Time Frame: 14 days ]Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
- Females of childbearing potential must employ an adequate method of birth control.
Inclusion criteria applicable to Screening period:
- 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.
Exclusion Criteria:
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.
- 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.
Exclusion criteria applicable to Screening period:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493089
Poland | |
Department of Gastroenterology and Hepatology, Oncology Centre, Roentgena | |
Warsaw, Poland, 02-781 |
Principal Investigator: | J Regula, MD | Dept of Gastroenterology and Hepatology, Roentgena, Warsaw, Poland |
Responsible Party: | Norgine |
ClinicalTrials.gov Identifier: | NCT01493089 |
Other Study ID Numbers: |
ZEG-01/2010 (GERD) |
First Posted: | December 15, 2011 Key Record Dates |
Results First Posted: | August 13, 2013 |
Last Update Posted: | August 13, 2013 |
Last Verified: | August 2013 |
Gastroesophageal Reflux Esophagitis, Peptic Heartburn Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Esophagitis Gastroenteritis |
Peptic Ulcer Duodenal Diseases Intestinal Diseases Stomach Diseases Signs and Symptoms, Digestive Omeprazole, sodium bicarbonate drug combination Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |