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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors

Study category: Digestive Health

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Description

The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments

Details
Age

Adult

Eligibility

The study population will consist of adult patients with diagnosed GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving QD PPI therapy and have evidence of pathological acid reflux during the Screening Period as determined using the Bravo device.

Detailed Eligibility: Inclusion Criteria To be eligible to participate in the study, patients must meet the following criteria: 1. Patient has signed an ICF before any study-specific procedures are performed. 2. Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit. 3. Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on average ≥ 4 days per week over the last 8 weeks before the Screening Visit. 4. Patient has been receiving standard-labeled dose, QD, PPI therapy (treatment that, according to the Investigator’s judgment, could not be further improved by changing the brand or timing of PPI administration) for a minimum of 8 weeks before the Screening

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Paul Menard-Katcher,  MD

Paul Menard-Katcher, MD

Study ID

Protocol Number: 18-2021

More information available at ClinicalTrials.gov: NCT03327727

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