Status:
COMPLETED
Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
Lead Sponsor:
Norgine
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01493089
Start Date
April 1 2011
End Date
October 1 2011
Last Update
August 13 2013
Active Locations (1)
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1
Department of Gastroenterology and Hepatology, Oncology Centre, Roentgena
Warsaw, Poland, 02-781