Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease

NCT01493089 | Completed Phase 3 Results

• 1 other identifier: ZEG-01/2010 (GERD)
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 14 days following treatment

Secondary Outcomes (5)

• Median Time to Sustained Partial Response

  up to 14 days

• Median Time to Sustained Total Relief

  14 days

• Percentage of Patients Responding in 45 Minutes

  up to 14 days

• Percentage of Patients Responding in 60 Minutes

  14 days

• Percentage of Patients Responding in 90 Minutes

  14 days

Study Arms (2)

Zegerid

EXPERIMENTAL

Treatment of heartburn with Zegerid

Drug: Zegerid

Losec

ACTIVE COMPARATOR

Treatment of heartburn with Losec

Drug: Losec

Interventions

Zegerid DRUG

20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.

Zegerid

Losec DRUG

20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.

Losec

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Department of Gastroenterology and Hepatology, Oncology Centre, Roentgena

Warsaw, 02-781, Poland

Location

Related Publications (1)

• 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.

  PMID: 25706883 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

omeprazole, sodium bicarbonate drug combination; Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Richard Ng Kwet Shing
• Organization: Norgine Ltd

RNg@Norgine.com

+441895453584

Study Officials

• J Regula, MD

  Dept of Gastroenterology and Hepatology, Roentgena, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 13, 2013
• Results First Posted: August 13, 2013

Record last verified: 2013-08

Locations

PL (1)