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Gastroesophageal Reflux Disease (GERD)Phase 3NCT03561883

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 101 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
609 participants
Where
101 sitesin 2 countries
Study dates
6 Sep 2018to 6 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

101 sites in 2 countries.

101 sites in 2 countries

United States98 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Asheville Gastroenterology Associates PA

    Asheville, North Carolina, 28801

  • Gastroenterology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana, 70809

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Commonwealth Clinical Studies LLC

    Brockton, Massachusetts, 02302

  • NYScientific

    Brooklyn, New York, 11235

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • Texas Health Physicians Group

    Carrollton, Texas, 75007

  • UNC Medical Center

    Chapel Hill, North Carolina, 27599

  • Clinical Trials of South Carolina - ClinEdge - PPDS

    Charleston, South Carolina, 29406

  • Pharmacorp Clinical Trials Incorporated

    Charleston, South Carolina, 29412

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Columbus Regional Research Institute at Talbotton

    Columbus, Georgia, 31904

  • Remington Davis Inc

    Columbus, Ohio, 43214

  • Optimus U Corp

    Coral Gables, Florida, 33134

  • Northside Gastroenterology

    Cypress, Texas, 77429

  • Dayton Gastroenterology Inc

    Dayton, Ohio, 45440

  • Consultative Gastroenterology

    Decatur, Georgia, 30034

  • Digestive Health Specialists of The Southeast

    Dothan, Alabama, 36305

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Gastrointestinal Associates PA

    Flowood, Mississippi, 39232

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Franklin Gastroenterology

    Franklin, Tennessee, 37067

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Gastroenterology Associates, PA

    Greenville, South Carolina, 29615

  • IL Gastroenterology Group

    Gurnee, Illinois, 60041

  • Medical Research Center of Connecticut LLC

    Hamden, Connecticut, 06518

  • Edward Hines Jr VA Hospital - NAVREF

    Hines, Illinois, 60141

  • Kelsey Research Foundation

    Houston, Texas, 77025

  • Houston Endoscopy and Research Center

    Houston, Texas, 77079

  • Coastal Medical Group

    Houston, Texas, 77089

  • Nature Coast Clinical Research LLC - ERN-PPDS

    Inverness, Florida, 34452

  • Clinical Research Solutions PC

    Jackson, Tennessee, 38305

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32207

  • United Health Services Hospitals

    Johnson City, New York, 13790

  • Kansas City VA Medical Center - NAVREF

    Kansas City, Missouri, 64128

  • Om Research LLC

    Lancaster, California, 93534

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

  • Office of Michael Zimmerman, MD

    Las Vegas, Nevada, 89128

  • Precision Clinical Research, LLC

    Lauderdale Lakes, Florida, 33319

  • Atria Clinical Research

    Little Rock, Arkansas, 72209

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Torrance Clinical Research

    Lomita, California, 90717

  • Suncoast Research Group LLC - ERN-PPDS

    Miami, Florida, 33135

  • Applemed Research Inc

    Miami, Florida, 33155

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Clinical Trials of America-NC, LLC

    Mount Airy, North Carolina, 27030

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • United Gastroenterologists

    Murrieta, California, 92563

  • QUALITY Medical Research - Interspond - PPDS

    Nashville, Tennessee, 37211

  • Aquiant Research

    New Albany, Indiana, 47150

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Clinical Trials of South Carolina

    North Charleston, South Carolina, 29406

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Lynn Health Science Institute - ERN-PPDS

    Oklahoma City, Oklahoma, 73112

  • Gutierrez Medical Center

    Orlando, Florida, 32807

  • Holland Center for Family Health

    Peoria, Arizona, 85381

  • Hope Research Institute LLC

    Peoria, Arizona, 85381

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania, 15241

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania, 15243

  • Northwest Gastroenterology Clinic

    Portland, Oregon, 97210

  • The Gastroenterology Group

    Reston, Virginia, 22191

  • Clinical Research Partners LLC

    Richmond, Virginia, 23220

  • Clinical Research Partners LLC

    Richmond, Virginia, 23235

  • Atlanta Center For Clinical Research

    Roswell, Georgia, 30075

  • PMG Research of Salisbury LLC

    Salisbury, North Carolina, 28144

  • Care Access Research

    Salt Lake City, Utah, 84124

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132-2101

  • University of Utah Hospital

    Salt Lake City, Utah, 84132-2101

  • San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)

    San Antonio, Texas, 78229

  • Clinical Applications Laboratories Inc

    San Diego, California, 92103

  • Care Access Research, San Pablo

    San Pablo, California, 94806

  • Paragon Rx Clinical, Inc. - Santa Ana

    Santa Ana, California, 92703

  • Guthrie Research Institute

    Sayre, Pennsylvania, 18840

  • Washington University

    St Louis, Missouri, 63110

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Clinical Research Atlanta - ERN-PPDS

    Stockbridge, Georgia, 30281

  • Aurora Medical Center Summit

    Summit, Wisconsin, 53066

  • Syracuse VA Medical Center - NAVREF

    Syracuse, New York, 13210

  • Advantage Clinical Trials

    The Bronx, New York, 10468

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • Center For Digestive Health

    Troy, Michigan, 48098

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Aurora Health Care

    Waukesha, Wisconsin, 53186

  • Advanced Clinical Research - Gut Whisperer- ERN-PPDS

    West Jordan, Utah, 84088

  • Clinical Trials of America LA LLC

    West Monroe, Louisiana, 71291

  • Heartland Research Associates LLC

    Wichita, Kansas, 67207

  • Trial Management Associates LLC

    Wilmington, North Carolina, 28403

  • Gastroenterology Associates of West Michigan

    Wyoming, Michigan, 49519

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan, 49519

Other trials in United States

Canada3 sites

  • Hughie Fraser, MD

    Bridgewater, Nova Scotia, B4V 3K9

  • Viable Clinical Research

    Bridgewater, Nova Scotia, B4V 3K9

  • 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 Inhibitor, 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 NCT03561883
Study groupRoleWhat they receive
1500 mg IW-3718 BIDExperimentalThree 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
PlaceboPlacebo 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 start6 Sep 2018
  3. Primary completion28 Jul 2020
  4. Study completion6 Nov 2020

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
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561883
Sponsor's protocol ID
C3718-302
Status last verified
Jul 2021
First submitted
7 Jun 2018
Last updated
18 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 101 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: finished, as of the sponsor's last update on 18 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 101 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 NCT03561883.

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 18 Aug 2021.

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