Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors
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|ClinicalTrials.gov Identifier: NCT03561883|
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : December 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease (GERD)||Drug: IW-3718 Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||609 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||October 30, 2020|
|Actual Study Completion Date :||November 6, 2020|
Experimental: 1500 mg IW-3718 BID
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals.
Placebo Comparator: Placebo
Three placebo tablets administered BID immediately after the morning and evening meals.
- Change From Baseline at Week 8 in Weekly Heartburn Severity Score (WHSS) [ Time Frame: Baseline, Week 8 ]The WHSS for a week is the average of the non-missing Daily Heartburn Severity Scores (DHSS) for that week. The DHSS for a day is the greater score of the 2 modified Reflux Symptom Questionnaire (mRESQ) items assessing heartburn severity ("Burning feeling behind the breastbone or in the center of the upper stomach" and "Pain behind the breastbone or in the center of the upper stomach") for that day.
- Change From Baseline at Week 8 in Weekly Regurgitation Frequency Score (WRFS) [ Time Frame: Baseline, Week 8 ]The WRFS for a week is the average of the non-missing Daily Regurgitation Frequency Scores (DRFS) for that week. DRFS for a day is the greater score of the 2 mRESQ items assessing regurgitation frequency ("Regurgitation [liquid or food moving upwards toward your throat or mouth]" and "An acid or bitter taste in the mouth") for that day.
- Proportion of Overall Heartburn Responders During the 8-Week Treatment Period [ Time Frame: Up to Week 8 ]An overall heartburn responder is defined as a participant who is a weekly heartburn responder for at least 4 weeks, including at least 1 of the last 2 weeks (Weeks 7 and 8), during the 8-week Treatment Period. A weekly heartburn responder is a participant with a decrease from baseline of ≥ 45% in Weekly Heartburn Severity Score (WHSS).
- 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.
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
|Study Chair:||Mike Shetzline, MD, PhD||Ironwood Pharmaceuticals, Inc.|