Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
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| ClinicalTrials.gov Identifier: NCT03561883 |
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Recruitment Status :
Completed
First Posted : June 19, 2018
Results First Posted : August 18, 2021
Last Update Posted : August 18, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) | Drug: IW-3718 Drug: placebo Drug: Standard-dose PPIs QD | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 609 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors |
| Actual Study Start Date : | September 6, 2018 |
| Actual Primary Completion Date : | July 28, 2020 |
| Actual Study Completion Date : | November 6, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1500 mg IW-3718 BID
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
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Drug: IW-3718
oral tablet Drug: Standard-dose PPIs QD background therapy |
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Placebo Comparator: Placebo
Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
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Drug: placebo
oral tablet Drug: Standard-dose PPIs QD background therapy |
- Change From Baseline in WHSS at Week 8 [ Time Frame: 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.
- Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 [ Time Frame: 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.
- Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period [ Time Frame: 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
- Proportion of Heartburn-Free Days During the 8-Week Treatment Period [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561883
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| Study Chair: | Mike Shetzline, MD, PhD | Ironwood Pharmaceuticals, Inc. |
Documents provided by Ironwood Pharmaceuticals, Inc.:
| Responsible Party: | Ironwood Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03561883 |
| Other Study ID Numbers: |
C3718-302 |
| First Posted: | June 19, 2018 Key Record Dates |
| Results First Posted: | August 18, 2021 |
| Last Update Posted: | August 18, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gastroesophageal Reflux Disease GERD Proton Pump Inhibitor IW-3718 |
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Gastroesophageal Reflux Esophagitis, Peptic Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Esophagitis Gastroenteritis Peptic Ulcer Duodenal Diseases Intestinal Diseases Stomach Diseases |