Phase 2
N=282
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT02637557 ↗Enrolled (actual)
282
Serious AEs
2.1%
Results posted
Oct 2019
Primary outcome: Primary: Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS) — -46.026; -48.978; -55.063; -57.969 percentage change in score — p=0.6065
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IW-3718 (Drug); Matching Placebo (Drug); PPI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS) |
-46.026; -48.978; -55.063; -57.969 | 0.6065 |
| SECONDARY Percent Change From Baseline to Week 4 in WHSS |
-38.883; -42.594; -41.622; -47.486 | 0.4795 |
| SECONDARY Change From Baseline to Week 8 in WHSS |
-1.459; -1.517; -1.713; -1.876 | 0.7488 |
| SECONDARY Change From Baseline to Week 4 in WHSS |
-1.261; -1.313; -1.308; -1.517 | 0.7470 |
| SECONDARY Percentage of Participants Who Are Overall Heartburn Responders |
54.3; 52.1; 62.0; 66.2 | 0.7903 |
| SECONDARY Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8 |
28.6; 18.3; 29.6; 38.2 | 0.1489 |
| SECONDARY Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4 |
12.9; 15.5; 22.5; 22.1 | 0.6566 |
| SECONDARY Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8 |
2.998; 2.700; 3.250; 3.510 | 0.5504 |
| SECONDARY Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4 |
2.275; 2.294; 2.694; 2.736 | 0.9675 |
| SECONDARY Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity' |
-0.655; -0.632; -0.531; -0.673; -0.994; -0.974 | 0.8560 |
| SECONDARY Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity' |
-0.638; -0.536; -0.492; -0.675; -0.998; -0.918 | 0.4137 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity' |
-0.602; -0.548; -0.454; -0.626; -0.921; -0.869 | 0.6663 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity' |
-0.498; -0.405; -0.309; -0.519; -0.618; -0.566 | 0.3788 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity' |
-0.329; -0.292; -0.400; -0.406; -0.483; -0.416 | 0.7207 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity' |
-0.426; -0.283; -0.353; -0.389; -0.574; -0.501 | 0.1922 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency' |
-0.483; -0.385; -0.340; -0.511; -0.647; -0.637 | 0.3007 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency' |
-0.502; -0.374; -0.401; -0.530; -0.738; -0.640 | 0.1902 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency' |
-0.374; -0.286; -0.290; -0.352; -0.572; -0.469 | 0.3258 |
| SECONDARY Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency' |
-0.459; -0.416; -0.309; -0.416; -0.669; -0.649 | 0.6653 |
| SECONDARY Change From Baseline in the Proportion of Heartburn-Free Days During Week 8 |
0.276; 0.256; 0.310; 0.347 | 0.7689 |
| SECONDARY Change From Baseline in the Proportion of Heartburn-Free Days During Week 4 |
0.141; 0.142; 0.134; 0.241 | 0.9961 |
Summary
The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
Eligibility Criteria
Inclusion Criteria
- Patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the Screening Visit. Lactating females must agree not to breastfeed.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit while taking standard QD PPI therapy.
Exclusion Criteria
- Patient may not meet any of the excluded conditions specified in the protocol
- Patient has any alarm symptoms including but not limited to GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the Screening or Pretreatment Periods
- Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo).
NOTE: Additional inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02637557). 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.