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NCT03561090 · ClinicalTrials.gov registry record · Phase 3
A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
A Phase 3 study, sponsored by Ironwood Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 495
- Enrollment target
NCT03561090: Clinical Trial Phase 3 study, sponsored by Ironwood Pharmaceuticals.
NCT03561090 is a Phase 3 study that was terminated before completion, run by Ironwood Pharmaceuticals. The registered enrollment target is 495 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03561090, a Phase 3 study, was terminated before completion, sponsored by Ironwood Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 495 participants
- Enrollment target
Study 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.
Primary Outcome
The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative cha
Interventions
- DRUG placebo
- DRUG IW-3718
- DRUG Standard-dose PPIs QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2020-11-03 |
| Phase | Phase 3 |
Why NCT03561090 stopped before completion
NCT03561090 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT03561090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03561090 about?
NCT03561090 is a clinical study titled "A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)". 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.
What is the current status of trial NCT03561090?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2018-06-20. Estimated completion is 2020-11-03.
What interventions are being tested in trial NCT03561090?
The interventions under investigation include: placebo (DRUG), IW-3718 (DRUG), Standard-dose PPIs QD (DRUG).
Who is sponsoring clinical trial NCT03561090?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03561090's enrollment target sits among peer trials
495 778th of 2000 higher than 1,222 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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