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NCT03561883 · ClinicalTrials.gov registry record · Phase 3
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.
- Completed
- Registry status
- Phase 3
- Development phase
- 609
- Enrollment target
NCT03561883: Completed Phase 3 study, sponsored by Ironwood Pharmaceuticals.
NCT03561883 is a Phase 3 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 609 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03561883, a Phase 3 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 609 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 | 609 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 3 |
What the finished NCT03561883 record still lists
NCT03561883 is an interventional study that assigns participants to a tested intervention. The registered 609 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 (21% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT03561883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03561883 about?
NCT03561883 is a clinical study titled "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 NCT03561883?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 609 participants. The study started on 2018-09-06. Estimated completion is 2020-11-06.
What interventions are being tested in trial NCT03561883?
The interventions under investigation include: placebo (DRUG), IW-3718 (DRUG), Standard-dose PPIs QD (DRUG).
Who is sponsoring clinical trial NCT03561883?
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 NCT03561883's enrollment target sits among peer trials
609 602nd of 2000 higher than 1,398 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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