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Gastroesophageal Reflux Disease (GERD)Phase 3NCT03561090

A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

A Phase 3 study testing IW-3718 and Standard-dose PPIs QD in people with Gastroesophageal Reflux Disease (GERD), run by Ironwood Pharmaceuticals, Inc. at 99 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Reflux Disease (GERD)
What is being tested?
IW-3718 and Standard-dose PPIs QD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
495 participants
Where
99 sitesin 2 countries
Study dates
20 Jun 2018to 3 Nov 2020
Phase
Phase 3
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

  • Each patient must meet all of the following criteria to be eligible for enrollment in this study:
  • Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit.
  • Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy.
  • Patient has evidence of pathological acid reflux.
  • Female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study.
  • Patient must comply with study procedures.

Who cannot join

  • Patients who meet any of the following criteria will not be eligible to participate in the study:
  • Patient has a history of complete lack of GERD symptom response to PPI therapy.
  • Patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia).
  • Patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the Screening Visit.
  • Patient has received an investigational drug during the 30 days before the Screening Visit, or is planning to receive another investigational drug or use an investigational device at any time during the study.
  • NOTE: Other inclusion and exclusion criteria apply, per the study protocol.

Trial locations and contacts

99 sites in 2 countries.

99 sites in 2 countries

United States93 sites

  • Lovelace Scientific Resources Inc

    Albuquerque, New Mexico, 87108

  • Anaheim Clinical Trials LLC - ERN-PPDS

    Anaheim, California, 92801

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Alan A Rosen MD PA

    Baltimore, Maryland, 21215

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • WR - ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Clinical Research Professionals

    Chesterfield, Missouri, 63141

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • GW Research, Inc.

    Chula Vista, California, 91910

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45219

  • West Central Gastroenterology, LLP

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Consultants of Gastroenterology

    Columbia, South Carolina, 29203

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Dallas VA Medical Center - NAVREF

    Dallas, Texas, 75231

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia, 30033

  • Avail Clinical Research LLC

    DeLand, Florida, 32720

  • AGA Clinical Research Associates, LLC. - MRA

    Egg Harbor, New Jersey, 08234

  • Elligo Health Research

    Frederick, Maryland, 21701

  • University of Florida

    Gainesville, Florida, 32610

  • GI Associates Gainesville

    Gainesville, Virginia, 20155

  • Digestive Health Associates of Texas

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • NYU School of Medicine

    Great Neck, New York, 11021

  • Medication Management LLC

    Greensboro, North Carolina, 27405

  • Meritus Center For Clinical Research

    Hagerstown, Maryland, 21742

  • Peters Medical Research, LLC

    High Point, North Carolina, 27262

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Biopharma Informatic Inc.

    Houston, Texas, 77043

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Research Consultants

    Houston, Texas, 77084

  • Houston Digestive Diseases Clinic

    Houston, Texas, 77090

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida, 32224

  • Borland Groover Clinic

    Jacksonville, Florida, 32256

  • East Carolina Gastroenterology

    Jacksonville, North Carolina, 28546

  • Multi Specialty Clinical Research

    Johnson City, Tennessee, 37601

  • Health Awareness Inc - MRA

    Jupiter, Florida, 33458

  • Kansas City Gastroenterology and Hepatology

    Kansas City, Missouri, 64131

  • Mayo Clinic Health System - Franciscan Healthcare - PPDS

    La Crosse, Wisconsin, 54601

  • Applied Research Center

    Little Rock, Arkansas, 72212

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • Clinical Trials Management LLC

    Mandeville, Louisiana, 70471

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Millennium Clinical Research Inc-Miami

    Miami, Florida, 33125

  • Wisconsin Center for Advanced Research Division of GI Associates

    Milwaukee, Wisconsin, 53215

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Alabama Medical Group, PC

    Mobile, Alabama, 36608

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Advanced Research Institute, Inc

    New Port Richey, Florida, 34653

  • Beth Israel Medical Center

    New York, New York, 10003

  • Manhattan Medical Research Practice PLLC

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Avicenna-DM Clinical Research

    Oak Lawn, Illinois, 60453

  • Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS

    Ocoee, Florida, 34761

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

  • Aspen Clinical Research LLC - MRA

    Orem, Utah, 84058

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Pearland Physicians

    Pearland, Texas, 77581

  • Pines Clinical Research Inc

    Pembroke Pines, Florida, 33028

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • DMI Research

    Pinellas Park, Florida, 33782

  • Veterans Research Foundation of Pittsburgh - NAVREF

    Pittsburgh, Pennsylvania, 15240

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • Legacy Research Institute

    Portland, Oregon, 97232

  • Wake Endoscopy Center

    Raleigh, North Carolina, 27607

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Advanced Research Institute - Reno

    Reno, Nevada, 89511

  • Northern California Research Corp

    Sacramento, California, 95821

  • Quality Research Inc

    San Antonio, Texas, 78209

  • Digestive Care Center

    San Carlos, California, 94070

  • Precision Research Institute

    San Diego, California, 92114

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • West Glen GI

    Shawnee Mission, Kansas, 66217

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Adobe Clinical Research LLC

    Tucson, Arizona, 85712

  • Advanced Gastroenterology-Union City

    Union City, Tennessee, 38237

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

Other trials in United States

Canada6 sites

  • ALTA Clinical Research Inc

    Edmonton, Alberta, T5A 4L8

  • Taunton Surgical Centre

    Oshawa, Ontario, L1H 3K4

  • Recherche Clinique Sigma, Inc.

    Québec, G1G 3Y8

  • Digestive Health Clinic

    Richmond Hill, Ontario, L4B 3P8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.

Being tested
IW-3718, placebo, Standard-dose PPIs QD
Keywords
Gastroesophageal Reflux Disease, GERD, Proton Pump Inhibitors, IW-3718
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

    oral tablet

  • placeboDrug

    oral tablet

  • Standard-dose PPIs QDDrug

    background therapy

Study groups in NCT03561090
Study groupRoleWhat they receive
1500 mg IW-3718 BID + PPIExperimentalThree 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
Receives: Drug: IW-3718; Drug: Standard-dose PPIs QD
Placebo + PPIPlacebo comparatorThree placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
Receives: Drug: placebo; Drug: Standard-dose PPIs QD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in WHSS at Week 8

    The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement.

    Measured: Baseline, Week 8

Secondary outcomes (3)

  1. Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8

    The WRFS is defined as the average of available daily regurgitation frequency scores (DRFS) during a week. DRFS is defined as the maximum score of the 2 items measuring regurgitation from a particular day (Item #6 "Regurgitation [liquid or food moving upwards toward your throat or mouth]" and Item #7 "An acid or bitter taste in the mouth"). The DRFS items are assessed on a 4-point ordinal scale, where 0=Never, 1=Rarely, 2-Sometimes, 3=Often, and 4=Very Often; higher scores indicate worse symptoms. A negative change from baseline indicates improvement.

    Measured: Baseline, Week 8

  2. Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period

    An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of >/= 45% from baseline in WHSS. A participant who reported heartburn severity for less than 4 days during a week is not considered a responder for that week.

    The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement

    Measured: Up to Week 8

  3. Proportion of Heartburn-Free Days During the 8-Week Treatment Period

    Proportion of heartburn-free days is calculated as the number of heartburn-free (DHSS=0) days divided by the number of diary entry days. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement

    Measured: Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start20 Jun 2018
  3. Primary completion7 Oct 2020
  4. Study completion3 Nov 2020

Why it stopped: Parallel IW-3718 Phase III trial did not meet pre-specified criteria.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561090
Sponsor's protocol ID
C3718-301
Status last verified
Aug 2021
First submitted
7 Jun 2018
Last updated
19 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IW-3718 and Standard-dose PPIs QD in people with Gastroesophageal Reflux Disease (GERD), run by Ironwood Pharmaceuticals, Inc. at 99 sites in 2 countries.

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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Aug 2021). 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?

Change From Baseline in WHSS at Week 8 (time frame: Baseline, 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 NCT03561090.

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 19 Aug 2021.

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