search
Back to results

A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IW-3718
Matching Placebo
PPI
Sponsored by
Ironwood Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator
  • IW-3718 Investigator

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control

500 mg IW-3718

1000 mg IW-3718

1500 mg IW-3718

Arm Description

Matching placebo twice daily

500 mg IW-3718 twice daily

1000 mg IW-3718 twice daily

1500 mg IW-3718 twice daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Percent Change From Baseline to Week 4 in WHSS
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Change From Baseline to Week 8 in WHSS
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Change From Baseline to Week 4 in WHSS
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Percentage of Participants Who Are Overall Heartburn Responders
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 >= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement.
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Change From Baseline in the Proportion of Heartburn-Free Days During Week 8
A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Change From Baseline in the Proportion of Heartburn-Free Days During Week 4
A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.

Full Information

First Posted
December 16, 2015
Last Updated
October 14, 2019
Sponsor
Ironwood Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02637557
Brief Title
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Official Title
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients With Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
April 26, 2017 (Actual)
Study Completion Date
April 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironwood Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Matching placebo twice daily
Arm Title
500 mg IW-3718
Arm Type
Experimental
Arm Description
500 mg IW-3718 twice daily
Arm Title
1000 mg IW-3718
Arm Type
Experimental
Arm Description
1000 mg IW-3718 twice daily
Arm Title
1500 mg IW-3718
Arm Type
Experimental
Arm Description
1500 mg IW-3718 twice daily
Intervention Type
Drug
Intervention Name(s)
IW-3718
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
PPI
Intervention Description
All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study.
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
Description
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Secondary Outcome Measure Information:
Title
Percent Change From Baseline to Week 4 in WHSS
Description
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
Title
Change From Baseline to Week 8 in WHSS
Description
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Title
Change From Baseline to Week 4 in WHSS
Description
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
Title
Percentage of Participants Who Are Overall Heartburn Responders
Description
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 >= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.
Time Frame
Week 8
Title
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8
Description
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.
Time Frame
Week 8
Title
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4
Description
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.
Time Frame
Week 4
Title
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8
Description
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Time Frame
Week 8
Title
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4
Description
DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Time Frame
Week 4
Title
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Description
The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.
Time Frame
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline in the Proportion of Heartburn-Free Days During Week 8
Description
A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Time Frame
Week 8
Title
Change From Baseline in the Proportion of Heartburn-Free Days During Week 4
Description
A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Lane
Organizational Affiliation
Ironwood Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
IW-3718 Investigator
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
IW-3718 Investigator
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
IW-3718 Investigator
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
IW-3718 Investigator
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
IW-3718 Investigator
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
IW-3718 Investigator
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
IW-3718 Investigator
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
IW-3718 Investigator
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
IW-3718 Investigator
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
IW-3718 Investigator
City
La Mirada
State/Province
California
ZIP/Postal Code
90638
Country
United States
Facility Name
IW-3718 Investigator
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
IW-3718 Investigator
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
IW-3718 Investigator
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
IW-3718 Investigator
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
IW-3718 Investigator
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
IW-3718 Investigator
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
IW-3718 Investigator
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
IW-3718 Investigator
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
IW-3718 Investigator
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
IW-3718 Investigator
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
IW-3718 Investigator
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
IW-3718 Investigator
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
IW-3718 Investigator
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
IW-3718 Investigator
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
IW-3718 Investigator
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
IW-3718 Investigator
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
IW-3718 Investigator
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
IW-3718 Investigator
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
IW-3718 Investigator
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
IW-3718 Investigator
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
IW-3718 Investigator
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
IW-3718 Investigator
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
IW-3718 Investigator
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
IW-3718 Investigator
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
IW-3718 Investigator
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
IW-3718 Investigator
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
IW-3718 Investigator
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
IW-3718 Investigator
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
IW-3718 Investigator
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
IW-3718 Investigator
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
IW-3718 Investigator
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
IW-3718 Investigator
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
IW-3718 Investigator
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
IW-3718 Investigator
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
IW-3718 Investigator
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
IW-3718 Investigator
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
IW-3718 Investigator
City
Lima
State/Province
Ohio
ZIP/Postal Code
45806
Country
United States
Facility Name
IW-3718 Investigator
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
IW-3718 Investigator
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
IW-3718 Investigator
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
IW-3718 Investigator
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
IW-3718 Investigator
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
IW-3718 Investigator
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
IW-3718 Investigator
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
IW-3718 Investigator
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
IW-3718 Investigator
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
IW-3718 Investigator
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
IW-3718 Investigator
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
IW-3718 Investigator
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
IW-3718 Investigator
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
IW-3718 Investigator
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
IW-3718 Investigator
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32092310
Citation
Vaezi MF, Fass R, Vakil N, Reasner DS, Mittleman RS, Hall M, Shao JZ, Chen Y, Lane L, Gates AM, Currie MG. IW-3718 Reduces Heartburn Severity in Patients With Refractory Gastroesophageal Reflux Disease in a Randomized Trial. Gastroenterology. 2020 Jun;158(8):2093-2103. doi: 10.1053/j.gastro.2020.02.031. Epub 2020 Feb 22.
Results Reference
derived
PubMed Identifier
31977454
Citation
Andrae DA, Hanlon J, Cala ML, Scippa K, Graham C, Witherspoon B, Shao JZ, Reasner D. Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. Clin Transl Gastroenterol. 2020 Jan;11(1):e00117. doi: 10.14309/ctg.0000000000000117.
Results Reference
derived

Learn more about this trial

A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

We'll reach out to this number within 24 hrs