Gastroesophageal Reflux DiseasePhase 2NCT02637557
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
A Phase 2 study testing IW-3718 and PPI in people with Gastroesophageal Reflux Disease, run by Ironwood Pharmaceuticals, Inc. at 62 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- IW-3718 and PPI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 62 sitesUnited States
- Study dates
- 1 Mar 2016to 26 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
IW-3718 Investigator
Anaheim, California, 92801
IW-3718 Investigator
Annapolis, Maryland, 21401
IW-3718 Investigator
Asheville, North Carolina, 28801
IW-3718 Investigator
Baltimore, Maryland, 21215
IW-3718 Investigator
Bowling Green, Kentucky, 42101
IW-3718 Investigator
Bristol, Connecticut, 06010
IW-3718 Investigator
Carmichael, California, 95608
IW-3718 Investigator
Charleston, South Carolina, 29412
IW-3718 Investigator
Chattanooga, Tennessee, 37421
IW-3718 Investigator
Chesterfield, Michigan, 48047
IW-3718 Investigator
Chevy Chase, Maryland, 20815
IW-3718 Investigator
Christiansburg, Virginia, 24073
IW-3718 Investigator
Chula Vista, California, 91910
IW-3718 Investigator
Cleveland, Ohio, 44109
IW-3718 Investigator
Clive, Iowa, 50325
IW-3718 Investigator
Columbus, Ohio, 43213
IW-3718 Investigator
DeLand, Florida, 32720
IW-3718 Investigator
Dothan, Alabama, 36305
IW-3718 Investigator
Egg Harbor, New Jersey, 08234
IW-3718 Investigator
El Paso, Texas, 79905
IW-3718 Investigator
Fargo, North Dakota, 58103
IW-3718 Investigator
Germantown, Tennessee, 38138
IW-3718 Investigator
Great Neck, New York, 11021
IW-3718 Investigator
Great Neck, New York, 11023
IW-3718 Investigator
Hollywood, Florida, 33024
IW-3718 Investigator
Houston, Texas, 77098
IW-3718 Investigator
Inverness, Florida, 34452
IW-3718 Investigator
Jupiter, Florida, 33458
IW-3718 Investigator
Kew Gardens, New York, 11415
IW-3718 Investigator
La Mirada, California, 90638
IW-3718 Investigator
Las Vegas, Nevada, 89128
IW-3718 Investigator
Lauderdale Lakes, Florida, 33319
IW-3718 Investigator
Lima, Ohio, 45806
IW-3718 Investigator
Lynchburg, Virginia, 24502
IW-3718 Investigator
Miami, Florida, 33126
IW-3718 Investigator
Miami, Florida, 33135
IW-3718 Investigator
Miami Lakes, Florida, 33014
IW-3718 Investigator
Mission Hills, California, 91345
IW-3718 Investigator
Monroe, Louisiana, 71201
IW-3718 Investigator
Nashville, Tennessee, 37232
IW-3718 Investigator
New York, New York, 10065
IW-3718 Investigator
Newport Beach, California, 92660
IW-3718 Investigator
Norman, Oklahoma, 73071
IW-3718 Investigator
North Little Rock, Arkansas, 72117
IW-3718 Investigator
Oakland, California, 94612
IW-3718 Investigator
Oklahoma City, Oklahoma, 73104
IW-3718 Investigator
Phoenix, Arizona, 85018
IW-3718 Investigator
Pittsburgh, Pennsylvania, 15243
IW-3718 Investigator
Port Orange, Florida, 32129
IW-3718 Investigator
Raleigh, North Carolina, 27612
IW-3718 Investigator
Reno, Nevada, 89511
IW-3718 Investigator
Sacramento, California, 95821
IW-3718 Investigator
San Antonio, Texas, 78209
IW-3718 Investigator
San Antonio, Texas, 78229
IW-3718 Investigator
San Diego, California, 92123
IW-3718 Investigator
Sandy City, Utah, 84092
IW-3718 Investigator
South Ogden, Utah, 84405
IW-3718 Investigator
Tucson, Arizona, 85710
IW-3718 Investigator
Tucson, Arizona, 85712
IW-3718 Investigator
Tucson, Arizona, 85741
IW-3718 Investigator
Waterbury, Connecticut, 06708
IW-3718 Investigator
Wyoming, Michigan, 49519
About this study
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
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).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- IW-3718, Matching Placebo, PPI
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-3718Drug
Matching PlaceboDrug
PPIDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Matching placebo twice daily Receives: Drug: Matching Placebo; Drug: PPI |
| 500 mg IW-3718 | Experimental | 500 mg IW-3718 twice daily Receives: Drug: IW-3718; Drug: PPI |
| 1000 mg IW-3718 | Experimental | 1000 mg IW-3718 twice daily Receives: Drug: IW-3718; Drug: PPI |
| 1500 mg IW-3718 | Experimental | 1500 mg IW-3718 twice daily Receives: Drug: IW-3718; Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Secondary outcomes (20)
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.
Measured: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
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.
Measured: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
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.
Measured: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
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.
Measured: Week 8
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.
Measured: Week 8
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.
Measured: Week 4
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.
Measured: Week 8
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.
Measured: Week 4
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Week 8
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start1 Mar 2016
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lara Lane, Study director, Ironwood Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637557
- Sponsor's protocol ID
- ICP-3718-202
- Status last verified
- Oct 2019
- First submitted
- 16 Dec 2015
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32092310Andrae 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.
PubMed 31977454
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02637557
- Acronym / sponsor ID
- ICP-3718-202
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Matching Placebo, Drug: PPIMatching placebo twice daily |
| 500 mg IW-3718 | Experimental | Drug: IW-3718, Drug: PPI500 mg IW-3718 twice daily |
| 1000 mg IW-3718 | Experimental | Drug: IW-3718, Drug: PPI1000 mg IW-3718 twice daily |
| 1500 mg IW-3718 | Experimental | Drug: IW-3718, Drug: PPI1500 mg IW-3718 twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IW-3718 | Drug | 1000 mg IW-3718, 1500 mg IW-3718, 500 mg IW-3718 |
| Matching Placebo | Drug | Control |
| PPIAll 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. | Drug | 1000 mg IW-3718, 1500 mg IW-3718, 500 mg IW-3718, Control |
Primary outcome
Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
Time frame: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
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.
20 secondary outcomes
Percent Change From Baseline to Week 4 in WHSS
Time frame: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
Change From Baseline to Week 8 in WHSS
Time frame: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Change From Baseline to Week 4 in WHSS
Time frame: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4
Percentage of Participants Who Are Overall Heartburn Responders
Time frame: Week 8
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8
Time frame: Week 8
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4
Time frame: Week 4
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8
Time frame: Week 8
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4
Time frame: Week 4
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
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
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
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
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
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
Change From Baseline in the Proportion of Heartburn-Free Days During Week 8
Time frame: Week 8
Change From Baseline in the Proportion of Heartburn-Free Days During Week 4
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32092310Vaezi 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.
- Derived from this study: PubMed 31977454Andrae 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Lane study director
Ironwood Pharmaceuticals, Inc.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IW-3718 and PPI in people with Gastroesophageal Reflux Disease, run by Ironwood Pharmaceuticals, Inc. at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS) (time frame: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637557, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.