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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03561883
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief 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), standarddose proton pump inhibitors (PPIs).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: IW-3718 Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: 1500 mg IW-3718 BID
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals.
Drug: IW-3718
oral tablet

Placebo Comparator: Placebo
Three placebo tablets administered BID immediately after the morning and evening meals.
Drug: placebo
oral tablet




Primary Outcome Measures :
  1. Proportion of Overall Heartburn Responders [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Proportion of Overall Heartburn Responders Among Participants With a Baseline Weekly Heartburn Severity Score (WHSS) ≥ 3 [ Time Frame: Week 8 ]
  2. Percent Change From Baseline to Week 8 in WHSS [ Time Frame: Baseline, Week 8 ]
  3. Percent Change From Baseline to Week 8 in Weekly Regurgitation Frequency Score (WRFS) [ Time Frame: Baseline, Week 8 ]
  4. Proportion of Heartburn-Free (Daily Heartburn Severity Score [DHSS]=0) Days During the 8-Week Treatment Period [ Time Frame: up to Week 8 ]
  5. Proportion of Overall Regurgitation Responders [ Time Frame: up to Week 8 ]
  6. Proportion of Days When Heartburn Did Not Occur (DHSS=0) or Was Very Mild (DHSS=1) During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  7. Proportion of Days When Regurgitation Did Not Occur (Daily Regurgitation Frequency Scores [DRFS]=0) or Rarely Occurred (DRFS=1) During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  8. Proportion of Regurgitation-Free (DRFS=0) Days During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  9. Change From Baseline to Week 8 in Each Modified Reflux Symptom Questionnaire Electronic Diary (mRESQ) Item [ Time Frame: Baseline, Week 8 ]
  10. Proportion of Nights With Difficulty Falling Asleep Due to GERD During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  11. Proportion of Days With Nighttime Awakening Due to GERD During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  12. Number of Degree of Relief (of Heartburn/Regurgitation/Overall GERD Symptoms) Responders [ Time Frame: up to Week 8 ]
  13. Change From Baseline to Week 8 in Heartburn/Regurgitation/Overall GERD Symptoms Bothersomeness [ Time Frame: Baseline, Week 8 ]
  14. Proportion of Days With Rescue Medication Use During the 8-Week Treatment Period [ Time Frame: up to Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 proton pump inhibitor (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.

Exclusion Criteria:

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, 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561883


Contacts
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Contact: Ironwood Study Team IW3718@ironwoodpharma.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Study Coordinator    205-934-4154    jcallaway@uabmc.edu   
Digestive Health Specialists of The Southeast Recruiting
Dothan, Alabama, United States, 36305
Contact: Study Coordinator    334-836-1055    trutland.research@dothangi.com   
United States, Arizona
Holland Center for Family Health Recruiting
Peoria, Arizona, United States, 85381
Contact: Study Coordinator    602-370-4691    drjholland@cactusclinicalresearch.com   
Hope Research Institute LLC Recruiting
Peoria, Arizona, United States, 85381
Contact: Study Coordinator    602-288-4673    michael.castro@hriaz.com   
United States, Arkansas
Atria Clinical Research Recruiting
Little Rock, Arkansas, United States, 72209
Contact: Study Coordinator    501-492-9175    drmeb@atriaresearch.com   
Preferred Research Partners Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Study Coordinator    501-553-9987    drbaberprp@gmail.com   
United States, California
Hope Clinical Research, LLC Recruiting
Canoga Park, California, United States, 91303
Contact: Study Coordinator    818-999-4673    haazami@hopeclinical.com   
Om Research LLC Recruiting
Lancaster, California, United States, 93534
Contact: Study Coordinator    661-388-2239    jpruthi@omclinicaltrials.com   
VA Loma Linda Healthcare System - NAVREF Not yet recruiting
Loma Linda, California, United States, 92357
Contact: Study Coordinator    909-825-7084    gisocal1@gmail.com   
Torrance Clinical Research Recruiting
Lomita, California, United States, 90717
Contact: Study Coordinator    310-373-8120    mraikhel@msn.com   
United Gastroenterologists Recruiting
Murrieta, California, United States, 92563
Contact: Study Coordinator    503-229-7137    egalen@nwgastro.net   
Clinical Applications Laboratories Inc Recruiting
San Diego, California, United States, 92103
Contact: Study Coordinator    619-260-1012    vijjilucky@gmail.com   
Care Access Research, San Pablo Recruiting
San Pablo, California, United States, 94806
Contact: Study Coordinator    415-408-8734    drkogan@careaccessresearch.com   
Paragon Rx Clinical, Inc. - Santa Ana Recruiting
Santa Ana, California, United States, 92703
Contact: Study Coordinator    714-539-3013    kelvin.mai@prxclinical.com   
United States, Connecticut
Yale School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Study Coordinator    203-737-6857    amir.masoud@yale.edu   
Stamford Therapeutics Consortium Recruiting
Stamford, Connecticut, United States, 06905
Contact: Study Coordinator    727-544-4842    dradinmd@gmail.com   
United States, Florida
Optimus U Corp Recruiting
Coral Gables, Florida, United States, 33134
Contact: Study Coordinator    305-702-0024    drgonzalez@optimusu.com   
Nature Coast Clinical Research LLC - ERN-PPDS Recruiting
Inverness, Florida, United States, 34452
Contact: Study Coordinator    352-341-2100    smathur@encoredocs.com   
Jacksonville Center For Clinical Research Recruiting
Jacksonville, Florida, United States, 32207
Contact: Study Coordinator    904-732-6683    bstottman@gmail.com   
Precision Clinical Research, LLC Recruiting
Lauderdale Lakes, Florida, United States, 33319
Contact: Study Coordinator    954-915-9991    research@sunrisemedresearch.com   
Suncoast Research Group LLC - ERN-PPDS Recruiting
Miami, Florida, United States, 33135
Contact: Study Coordinator    786-344-3845    froblespena@gastromedmiami.com   
Applemed Research Inc Recruiting
Miami, Florida, United States, 33155
Contact: Study Coordinator    305-667-8434    dr.latorre@applemedresearch.org   
Gutierrez Medical Center Recruiting
Orlando, Florida, United States, 32807
Contact: Study Coordinator    407-203-6898    jg@gmedcenter.com   
United States, Georgia
Consultative Gastroenterology Not yet recruiting
Decatur, Georgia, United States, 30034
Contact: Study Coordinator    770-987-7428    mednetresearch@aol.com   
Atlanta Center For Clinical Research Recruiting
Roswell, Georgia, United States, 30075
Contact: Study Coordinator    770-645-7866    vogmd@atlccr.com   
Clinical Research Atlanta - ERN-PPDS Recruiting
Stockbridge, Georgia, United States, 30281
Contact: Study Coordinator    770-507-6867    nsegall@clinicalresearchatlanta.com   
United States, Illinois
IL Gastroenterology Group Not yet recruiting
Gurnee, Illinois, United States, 60041
Contact: Study Coordinator    847-244-2960    frosenberg@illinoisgastro.com   
Edward Hines Jr VA Hospital - NAVREF Not yet recruiting
Hines, Illinois, United States, 60141
Contact: Study Coordinator    708-202-2710    promila.banerjee@va.gov   
United States, Indiana
Aquiant Research Not yet recruiting
New Albany, Indiana, United States, 47150
Contact: Study Coordinator    812-206-1702    ebizer@gmail.com   
United States, Kansas
Kansas Medical Clinic Not yet recruiting
Topeka, Kansas, United States, 66606
Contact: Study Coordinator    785-354-8518    schalla@aol.com   
Heartland Research Associates LLC Recruiting
Wichita, Kansas, United States, 67207
Contact: Study Coordinator    316-689-6645    tck@heartlandresearch.com   
United States, Louisiana
Gastroenterology Associates LLC Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Study Coordinator    225-927-1190 ext 7850    palapati@dhcla.com   
Clinical Trials of America LA LLC Recruiting
West Monroe, Louisiana, United States, 71291
Contact: Study Coordinator    318-737-1095    bdunn@ctamerica.net   
United States, Maryland
Investigative Clinical Research Recruiting
Annapolis, Maryland, United States, 21401
Contact: Study Coordinator    410-224-4887    michael@icrmd.com   
Centennial Medical Group Recruiting
Elkridge, Maryland, United States, 21075
Contact: Study Coordinator    410-730-3399    drg@centennialmedical.com   
United States, Massachusetts
Commonwealth Clinical Studies LLC Not yet recruiting
Brockton, Massachusetts, United States, 02302
Contact: Study Coordinator    508-588-9900    jstern@gisdoc.com   
United States, Michigan
Center For Digestive Health Recruiting
Troy, Michigan, United States, 48098
Contact: Study Coordinator    248-267-6605    jweberres@gmail.com   
Gastroenterology Associates of West Michigan Recruiting
Wyoming, Michigan, United States, 49519
Contact: Study Coordinator    616-608-8730    acoates@gastro-assoc-wm.com   
United States, Mississippi
Gastrointestinal Associates PA Recruiting
Flowood, Mississippi, United States, 39232
Contact: Study Coordinator    601-863-0395    rhogan3.research@gi.md   
United States, Missouri
Kansas City VA Medical Center - NAVREF Not yet recruiting
Kansas City, Missouri, United States, 64128
Contact: Study Coordinator    801-587-5597    psharma@kumc.edu   
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-3969    cprakash@dom.wustl.edu   
United States, Nevada
Office of Michael Zimmerman, MD Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Study Coordinator    702-385-0046    drmzimmerman@lvresearch.com   
United States, New York
Advantage Clinical Trials Recruiting
Bronx, New York, United States, 10468
Contact: Study Coordinator    917-962-0234    gianguido2386@gmail.com   
NYScientific Recruiting
Brooklyn, New York, United States, 11235
Contact: Study Coordinator    347-547-6972    igrosman@nyscientific.net   
Long Island Gastrointestinal Research Group LLP Recruiting
Great Neck, New York, United States, 11023
Contact: Study Coordinator    516-482-5976    michaelgoldstein@ligiresearch.com   
United Health Services Hospitals Not yet recruiting
Johnson City, New York, United States, 13790
Contact: Study Coordinator    607-798-7345    hilagi@hotmail.com   
Syracuse VA Medical Center - NAVREF Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Study Coordinator    315-425-4400    uma.murthy@va.gov   
United States, North Carolina
Asheville Gastroenterology Associates PA Recruiting
Asheville, North Carolina, United States, 28801
Contact: Study Coordinator    828-254-0881    adukowicz@ncdhp.com   
UNC Medical Center Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Study Coordinator    919-966-7074    nshaheen@med.unc.edu   
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Study Coordinator    919-668-7924    david.leiman@duke.edu   
Carolina Digestive Diseases Recruiting
Greenville, North Carolina, United States, 27834
Contact: Study Coordinator    252-758-8181    pgoldstein@cddgastro.com   
Clinical Trials of America-NC, LLC Recruiting
Mount Airy, North Carolina, United States, 27030
Contact: Study Coordinator    336-415-5507    gpfitzner@ctamerica.net   
PMG Research of Salisbury LLC Recruiting
Salisbury, North Carolina, United States, 28144
Contact: Study Coordinator    704-647-9913    kiranjagar@gmail.com   
Trial Management Associates LLC Recruiting
Wilmington, North Carolina, United States, 28403
Contact: Study Coordinator    910-833-1954    dcarney@trialmgt.com   
United States, Ohio
Hightop Medical Research Center Recruiting
Cincinnati, Ohio, United States, 45224
Contact: Study Coordinator    513-681-0606    jamesfidelholtz@hotmail.com   
MetroHealth Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Study Coordinator    216-778-5736    rfass@metrohealth.org; ronnie.fass@gmail.com   
Remington Davis Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: Study Coordinator    614-487-2560    ibaird@remdavis.com   
Dayton Gastroenterology Inc Recruiting
Dayton, Ohio, United States, 45440
Contact: Study Coordinator    937-320-5050    rwille@daytongastro.com   
Prestige Clinical Research Recruiting
Franklin, Ohio, United States, 45005
Contact: Study Coordinator    937-746-4505    gary_bedel@yahoo.com   
United States, Oklahoma
Central Sooner Research Recruiting
Norman, Oklahoma, United States, 73071
Contact: Study Coordinator    405-329-0474    ewiesner@centralsooner.com   
The University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Study Coordinator    405-271-5428    salman-nusrat@ouhsc.edu   
Lynn Health Science Institute - ERN-PPDS Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Study Coordinator    405-602-3927    cgriffin1956@yahoo.com   
United States, Oregon
Northwest Gastroenterology Clinic Active, not recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Research Protocol Management Specialists Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Study Coordinator    412-942-0010    dave_limauro@yahoo.com   
Guthrie Research Institute Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Study Coordinator    570-887-5415    michael.georgetson@guthrie.org   
United States, Rhode Island
Omega Medical Research Not yet recruiting
Warwick, Rhode Island, United States, 02886
Contact: Study Coordinator    401-739-9350 ext 228    dr.newton@omegamedicalresearch.com   
United States, South Carolina
Pharmacorp Clinical Trials Incorporated Recruiting
Charleston, South Carolina, United States, 29412
Contact: Study Coordinator    843-795-1710    hdurrence@phchealth.com   
Gastroenterology Associates, PA Recruiting
Greenville, South Carolina, United States, 29615
Contact: Study Coordinator    864-232-7338    skimmd@gastroassociates.com   
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Study Coordinator    843-856-2848    cstrout@coastalcarolinaresearch.com   
Clinical Trials of South Carolina Recruiting
North Charleston, South Carolina, United States, 29406
Contact: Study Coordinator    843-725-5067    etavel@painchas.com   
United States, Tennessee
Clinical Research Solutions PC Recruiting
Jackson, Tennessee, United States, 38305
Contact: Study Coordinator    731-431-5027    Dr.BSouder@crssites.com   
QUALITY Medical Research - Interspond - PPDS Not yet recruiting
Nashville, Tennessee, United States, 37211
Contact: Study Coordinator    615-835-4750    rherring@qualitymedicalresearch.com   
United States, Texas
Inquest Clinical Research Recruiting
Baytown, Texas, United States, 77521
Contact: Study Coordinator    281-428-8203    haiderafzal14@gmail.com   
Texas Health Physicians Group Not yet recruiting
Carrollton, Texas, United States, 75007
Contact: Study Coordinator    972-492-2776    joseburbano@texashealth.org   
Texas Tech University Health Sciences Center Not yet recruiting
El Paso, Texas, United States, 79905
Contact: Study Coordinator    915-215-5205    marc.zuckerman@ttuhsc.edu   
Kelsey Research Foundation Not yet recruiting
Houston, Texas, United States, 77025
Contact: Study Coordinator    713-442-1223    greg.galler@kelsey-seybold.com   
Coastal Medical Group Active, not recruiting
Houston, Texas, United States, 77089
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC) Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-558-2794 ext 2218    js_bull@yahoo.com   
United States, Utah
Care Access Research Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Study Coordinator    415-408-8734    pjpedersen@careaccessresearch.com   
University of Utah Health Sciences Center Not yet recruiting
Salt Lake City, Utah, United States, 84132-2101
Contact: Study Coordinator    801-581-2121    andrew.gawron@hsc.utah.edu   
Advanced Clinical Research - Gut Whisperer- ERN-PPDS Recruiting
West Jordan, Utah, United States, 84088
Contact: Study Coordinator    801-542-8190    ksmith@acr-research.com   
United States, Virginia
Digestive and Liver Disease Specialists Recruiting
Norfolk, Virginia, United States, 23502
Contact: Study Coordinator    757-466-0165    dajresearch@dlds.org   
The Gastroenterology Group Not yet recruiting
Reston, Virginia, United States, 22191
Contact: Study Coordinator    703-766-2650    lakhani13@aol.com   
Clinical Research Partners LLC Recruiting
Richmond, Virginia, United States, 23220
Contact: Study Coordinator    804-477-3045    rsc@crpllc.info   
Clinical Research Partners LLC Recruiting
Richmond, Virginia, United States, 23235
Contact: Study Coordinator    804-308-8659    jjamesmd@crpllc.info   
United States, Wisconsin
Aurora Health Care Recruiting
Waukesha, Wisconsin, United States, 53186
Contact: Study Coordinator    262-896-6346      
Canada, Nova Scotia
Hughie Fraser, MD Not yet recruiting
Bridgewater, Nova Scotia, Canada, B4V 3K9
Contact: Study Coordinator    (902) 530-3216    hughie.fraser@gmail.com   
Canada, Ontario
Toronto Digestive Disease Associates Inc Not yet recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Contact: Study Coordinator    (416) 650-0017    tptak@tdda.ca   
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Investigators
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Study Chair: Zurab Machaidze, MD Ironwood Pharmaceuticals, Inc.

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Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03561883     History of Changes
Other Study ID Numbers: C3718-302
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Gastroesophageal Reflux Disease
GERD
Proton Pump Inhibitor
IW-3718

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action