Trial · NCT03561883
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
NCT03561883, Phase 3, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2021-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs). Trials, record NCT03561883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03561883
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
- NCT number
- NCT03561883
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 609 participants, actual
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- IW-3718, placebo, Standard-dose PPIs QD
- First posted
- 2018-06-19
- Last updated
- 2021-08-18
- Results first posted
- 2021-08-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in WHSS at Week 8 | Baseline, Week 8 | 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 change from baseline indicates improvement. |
| Secondary | Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 | Baseline, Week 8 | The WRFS is defined as the average of available daily regurgitation frequency scores (DRFS) during a week. DRFS is defined as the maximum score of the 2 items measuring regurgitation from a particular day (Item #6 "Regurgitation \[liquid or food moving upwards toward your throat or mouth\]" and Item #7 "An acid or bitter taste in the mouth"). The DRFS items are assessed on a 4-point ordinal scale, where 0=Never, 1=Rarely, 2-Sometimes, 3=Often, and 4=Very Often; higher scores indicate worse symptoms. A negative change from baseline indicates improvement. |
| Secondary | Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period | Up to Week 8 | An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of \>/= 45% from baseline in WHSS. A participant who reported heartburn severity for less than 4 days during a week is not considered a responder for that week. 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 change from baseline indicates improvement |
| Secondary | Proportion of Heartburn-Free Days During the 8-Week Treatment Period | Up to Week 8 | Proportion of heartburn-free days is calculated as the number of heartburn-free (DHSS=0) days divided by the number of diary entry days. 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 change from baseline indicates improvement |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in WHSS at Week 8 | Baseline, Week 8 | mITT Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 | Baseline, Week 8 | mITT Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period | Up to Week 8 | Modified Intent-to-Treat (mITT) Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Heartburn-Free Days During the 8-Week Treatment Period | Up to Week 8 | mITT Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | proportion of days | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in WHSS at Week 8 | Placebo BID + PPIs | -1.751 | Standard Error 0.081 | score on a scale | |
| Change From Baseline in WHSS at Week 8 | 1500 mg IW-3718 BID + PPIs | -1.814 | Standard Error 0.082 | score on a scale | |
| Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 | Placebo BID + PPIs | -1.278 | Standard Error 0.065 | score on a scale | |
| Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 | 1500 mg IW-3718 BID + PPIs | -1.287 | Standard Error 0.065 | score on a scale | |
| Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period | Placebo BID + PPIs | 41.3 | percentage of participants | ||
| Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period | 1500 mg IW-3718 BID + PPIs | 42.6 | percentage of participants | ||
| Proportion of Heartburn-Free Days During the 8-Week Treatment Period | Placebo BID + PPIs | 0.200 | Standard Error 0.030 | proportion of days | |
| Proportion of Heartburn-Free Days During the 8-Week Treatment Period | 1500 mg IW-3718 BID + PPIs | 0.234 | Standard Error 0.033 | proportion of days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo BID + PPIs | 305 | |
| Overall Study | STARTED | 1500 mg IW-3718 BID + PPIs | 304 | |
| Overall Study | COMPLETED | Placebo BID + PPIs | 259 | |
| Overall Study | COMPLETED | 1500 mg IW-3718 BID + PPIs | 261 | |
| Overall Study | NOT COMPLETED | Placebo BID + PPIs | 46 | |
| Overall Study | NOT COMPLETED | 1500 mg IW-3718 BID + PPIs | 43 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo BID + PPIs | 4 | 304 | |
| other | Constipation | Gastrointestinal disorders | 1500 mg IW-3718 BID + PPIs | 9 | 304 | |
| other | Nausea | Gastrointestinal disorders | Placebo BID + PPIs | 2 | 304 | |
| other | Nausea | Gastrointestinal disorders | 1500 mg IW-3718 BID + PPIs | 8 | 304 | |
| serious | Pulseless electrical activity | Cardiac disorders | Placebo BID + PPIs | 1 | 304 | |
| serious | Pulseless electrical activity | Cardiac disorders | 1500 mg IW-3718 BID + PPIs | 0 | 304 | |
| serious | Oesophageal stenosis | Gastrointestinal disorders | Placebo BID + PPIs | 1 | 304 | |
| serious | Oesophageal stenosis | Gastrointestinal disorders | 1500 mg IW-3718 BID + PPIs | 0 | 304 | |
| serious | Non-cardiac chest pain | General disorders | Placebo BID + PPIs | 1 | 304 | |
| serious | Non-cardiac chest pain | General disorders | 1500 mg IW-3718 BID + PPIs | 0 | 304 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo BID + PPIs | 1 | 304 |
| Total, all-cause mortality | 1500 mg IW-3718 BID + PPIs | 0 | 304 |
| Total, other adverse events | Placebo BID + PPIs | 6 | 304 |
| Total, other adverse events | 1500 mg IW-3718 BID + PPIs | 15 | 304 |
| Total, serious adverse events | Placebo BID + PPIs | 3 | 304 |
| Total, serious adverse events | 1500 mg IW-3718 BID + PPIs | 2 | 304 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo BID + PPIs vs 1500 mg IW-3718 BID + PPIs: deaths from any cause | Trial comparisons |
| Placebo BID + PPIs vs 1500 mg IW-3718 BID + PPIs: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03561883
GET https://conductscience.org/api/trials/v1/NCT03561883/registered