A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
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
1 other identifier
interventional
282
1 country
62
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2016
Shorter than P25 for phase_2
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2017
CompletedResults Posted
Study results publicly available
October 15, 2019
CompletedOctober 15, 2019
October 1, 2019
1.2 years
December 16, 2015
September 23, 2019
October 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Secondary Outcomes (20)
Percent Change From Baseline to Week 4 in WHSS
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
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
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
Week 8
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8
Week 8
- +15 more secondary outcomes
Study Arms (4)
Control
PLACEBO COMPARATORMatching placebo twice daily
500 mg IW-3718
EXPERIMENTAL500 mg IW-3718 twice daily
1000 mg IW-3718
EXPERIMENTAL1000 mg IW-3718 twice daily
1500 mg IW-3718
EXPERIMENTAL1500 mg IW-3718 twice daily
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
IW-3718 Investigator
Dothan, Alabama, 36305, United States
IW-3718 Investigator
Phoenix, Arizona, 85018, United States
IW-3718 Investigator
Tucson, Arizona, 85710, United States
IW-3718 Investigator
Tucson, Arizona, 85712, United States
IW-3718 Investigator
Tucson, Arizona, 85741, United States
IW-3718 Investigator
North Little Rock, Arkansas, 72117, United States
IW-3718 Investigator
Anaheim, California, 92801, United States
IW-3718 Investigator
Carmichael, California, 95608, United States
IW-3718 Investigator
Chula Vista, California, 91910, United States
IW-3718 Investigator
La Mirada, California, 90638, United States
IW-3718 Investigator
Mission Hills, California, 91345, United States
IW-3718 Investigator
Newport Beach, California, 92660, United States
IW-3718 Investigator
Oakland, California, 94612, United States
IW-3718 Investigator
Sacramento, California, 95821, United States
IW-3718 Investigator
San Diego, California, 92123, United States
IW-3718 Investigator
Bristol, Connecticut, 06010, United States
IW-3718 Investigator
Waterbury, Connecticut, 06708, United States
IW-3718 Investigator
DeLand, Florida, 32720, United States
IW-3718 Investigator
Hollywood, Florida, 33024, United States
IW-3718 Investigator
Inverness, Florida, 34452, United States
IW-3718 Investigator
Jupiter, Florida, 33458, United States
IW-3718 Investigator
Lauderdale Lakes, Florida, 33319, United States
IW-3718 Investigator
Miami, Florida, 33126, United States
IW-3718 Investigator
Miami, Florida, 33135, United States
IW-3718 Investigator
Miami Lakes, Florida, 33014, United States
IW-3718 Investigator
Port Orange, Florida, 32129, United States
IW-3718 Investigator
Clive, Iowa, 50325, United States
IW-3718 Investigator
Bowling Green, Kentucky, 42101, United States
IW-3718 Investigator
Monroe, Louisiana, 71201, United States
IW-3718 Investigator
Annapolis, Maryland, 21401, United States
IW-3718 Investigator
Baltimore, Maryland, 21215, United States
IW-3718 Investigator
Chevy Chase, Maryland, 20815, United States
IW-3718 Investigator
Chesterfield, Michigan, 48047, United States
IW-3718 Investigator
Wyoming, Michigan, 49519, United States
IW-3718 Investigator
Las Vegas, Nevada, 89128, United States
IW-3718 Investigator
Reno, Nevada, 89511, United States
IW-3718 Investigator
Egg Harbor, New Jersey, 08234, United States
IW-3718 Investigator
Great Neck, New York, 11021, United States
IW-3718 Investigator
Great Neck, New York, 11023, United States
IW-3718 Investigator
Kew Gardens, New York, 11415, United States
IW-3718 Investigator
New York, New York, 10065, United States
IW-3718 Investigator
Asheville, North Carolina, 28801, United States
IW-3718 Investigator
Raleigh, North Carolina, 27612, United States
IW-3718 Investigator
Fargo, North Dakota, 58103, United States
IW-3718 Investigator
Cleveland, Ohio, 44109, United States
IW-3718 Investigator
Columbus, Ohio, 43213, United States
IW-3718 Investigator
Lima, Ohio, 45806, United States
IW-3718 Investigator
Norman, Oklahoma, 73071, United States
IW-3718 Investigator
Oklahoma City, Oklahoma, 73104, United States
IW-3718 Investigator
Pittsburgh, Pennsylvania, 15243, United States
IW-3718 Investigator
Charleston, South Carolina, 29412, United States
IW-3718 Investigator
Chattanooga, Tennessee, 37421, United States
IW-3718 Investigator
Germantown, Tennessee, 38138, United States
IW-3718 Investigator
Nashville, Tennessee, 37232, United States
IW-3718 Investigator
El Paso, Texas, 79905, United States
IW-3718 Investigator
Houston, Texas, 77098, United States
IW-3718 Investigator
San Antonio, Texas, 78209, United States
IW-3718 Investigator
San Antonio, Texas, 78229, United States
IW-3718 Investigator
Sandy City, Utah, 84092, United States
IW-3718 Investigator
South Ogden, Utah, 84405, United States
IW-3718 Investigator
Christiansburg, Virginia, 24073, United States
IW-3718 Investigator
Lynchburg, Virginia, 24502, United States
Related Publications (2)
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.
PMID: 32092310DERIVEDAndrae 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.
PMID: 31977454DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- IW-3718-202 Study Chair
- Organization
- Ironwood Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Lara Lane
Ironwood Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 22, 2015
Study Start
March 1, 2016
Primary Completion
April 26, 2017
Study Completion
April 26, 2017
Last Updated
October 15, 2019
Results First Posted
October 15, 2019
Record last verified: 2019-10