Phase 3
Completed N=609
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Gastroesophageal Reflux Disease (GERD)
Source: ClinicalTrials.gov NCT03561883 ↗
Enrolled (actual)
609
Serious AEs
0.8%
Results posted
Aug 2021
Primary outcomePrimary: Change From Baseline in WHSS at Week 8 — -1.751; -1.814 score on a scale — p=0.5566
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in WHSS at Week 8 |
-1.751; -1.814 | 0.5566 |
| SECONDARY Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 |
-1.278; -1.287 | 0.9226 |
| SECONDARY Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period |
41.3; 42.6 | 0.7424 |
| SECONDARY Proportion of Heartburn-Free Days During the 8-Week Treatment Period |
0.200; 0.234 | 0.4164 |
Eligibility Criteria
Inclusion Criteria
Each patient must meet all of the following criteria to be eligible for enrollment in this study:
- Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy.
- Patient has evidence of pathological acid reflux.
- Female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study.
- Patient must comply with study procedures.
Exclusion Criteria
Patients who meet any of the following criteria will not be eligible to participate in the study:
- Patient has a history of complete lack of GERD symptom response to PPI therapy.
- Patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia).
- Patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the Screening Visit.
- Patient has received an investigational drug during the 30 days before the Screening Visit, or is planning to receive another investigational drug or use an investigational device at any time during the study.
NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
Data sourced from ClinicalTrials.gov (NCT03561883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.