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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02637557
Other study ID # ICP-3718-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 1, 2016
Est. completion date April 26, 2017

Study information

Verified date October 2019
Source Ironwood Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date April 26, 2017
Est. primary completion date April 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
IW-3718

Matching Placebo

PPI
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.

Locations

Country Name City State
United States IW-3718 Investigator Anaheim California
United States IW-3718 Investigator Annapolis Maryland
United States IW-3718 Investigator Asheville North Carolina
United States IW-3718 Investigator Baltimore Maryland
United States IW-3718 Investigator Bowling Green Kentucky
United States IW-3718 Investigator Bristol Connecticut
United States IW-3718 Investigator Carmichael California
United States IW-3718 Investigator Charleston South Carolina
United States IW-3718 Investigator Chattanooga Tennessee
United States IW-3718 Investigator Chesterfield Michigan
United States IW-3718 Investigator Chevy Chase Maryland
United States IW-3718 Investigator Christiansburg Virginia
United States IW-3718 Investigator Chula Vista California
United States IW-3718 Investigator Cleveland Ohio
United States IW-3718 Investigator Clive Iowa
United States IW-3718 Investigator Columbus Ohio
United States IW-3718 Investigator DeLand Florida
United States IW-3718 Investigator Dothan Alabama
United States IW-3718 Investigator Egg Harbor Township New Jersey
United States IW-3718 Investigator El Paso Texas
United States IW-3718 Investigator Fargo North Dakota
United States IW-3718 Investigator Germantown Tennessee
United States IW-3718 Investigator Great Neck New York
United States IW-3718 Investigator Great Neck New York
United States IW-3718 Investigator Hollywood Florida
United States IW-3718 Investigator Houston Texas
United States IW-3718 Investigator Inverness Florida
United States IW-3718 Investigator Jupiter Florida
United States IW-3718 Investigator Kew Gardens New York
United States IW-3718 Investigator La Mirada California
United States IW-3718 Investigator Las Vegas Nevada
United States IW-3718 Investigator Lauderdale Lakes Florida
United States IW-3718 Investigator Lima Ohio
United States IW-3718 Investigator Lynchburg Virginia
United States IW-3718 Investigator Miami Florida
United States IW-3718 Investigator Miami Florida
United States IW-3718 Investigator Miami Lakes Florida
United States IW-3718 Investigator Mission Hills California
United States IW-3718 Investigator Monroe Louisiana
United States IW-3718 Investigator Nashville Tennessee
United States IW-3718 Investigator New York New York
United States IW-3718 Investigator Newport Beach California
United States IW-3718 Investigator Norman Oklahoma
United States IW-3718 Investigator North Little Rock Arkansas
United States IW-3718 Investigator Oakland California
United States IW-3718 Investigator Oklahoma City Oklahoma
United States IW-3718 Investigator Phoenix Arizona
United States IW-3718 Investigator Pittsburgh Pennsylvania
United States IW-3718 Investigator Port Orange Florida
United States IW-3718 Investigator Raleigh North Carolina
United States IW-3718 Investigator Reno Nevada
United States IW-3718 Investigator Sacramento California
United States IW-3718 Investigator San Antonio Texas
United States IW-3718 Investigator San Antonio Texas
United States IW-3718 Investigator San Diego California
United States IW-3718 Investigator Sandy Utah
United States IW-3718 Investigator South Ogden Utah
United States IW-3718 Investigator Tucson Arizona
United States IW-3718 Investigator Tucson Arizona
United States IW-3718 Investigator Tucson Arizona
United States IW-3718 Investigator Waterbury Connecticut
United States IW-3718 Investigator Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Secondary 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. Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
Secondary 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. Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Secondary 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. Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
Secondary 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. Week 8
Secondary 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. Week 8
Secondary 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. Week 4
Secondary 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. Week 8
Secondary 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. Week 4
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. Week 8
Secondary 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. Week 4
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