A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT02637557
Last Updated: 2019-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2016-03-01
2017-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
Matching placebo twice daily
Matching Placebo
PPI
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.
500 mg IW-3718
500 mg IW-3718 twice daily
IW-3718
PPI
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.
1000 mg IW-3718
1000 mg IW-3718 twice daily
IW-3718
PPI
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.
1500 mg IW-3718
1500 mg IW-3718 twice daily
IW-3718
PPI
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.
Interventions
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IW-3718
Matching Placebo
PPI
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
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lara Lane
Role: STUDY_DIRECTOR
Ironwood Pharmaceuticals, Inc.
Locations
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IW-3718 Investigator
Dothan, Alabama, United States
IW-3718 Investigator
Phoenix, Arizona, United States
IW-3718 Investigator
Tucson, Arizona, United States
IW-3718 Investigator
Tucson, Arizona, United States
IW-3718 Investigator
Tucson, Arizona, United States
IW-3718 Investigator
North Little Rock, Arkansas, United States
IW-3718 Investigator
Anaheim, California, United States
IW-3718 Investigator
Carmichael, California, United States
IW-3718 Investigator
Chula Vista, California, United States
IW-3718 Investigator
La Mirada, California, United States
IW-3718 Investigator
Mission Hills, California, United States
IW-3718 Investigator
Newport Beach, California, United States
IW-3718 Investigator
Oakland, California, United States
IW-3718 Investigator
Sacramento, California, United States
IW-3718 Investigator
San Diego, California, United States
IW-3718 Investigator
Bristol, Connecticut, United States
IW-3718 Investigator
Waterbury, Connecticut, United States
IW-3718 Investigator
DeLand, Florida, United States
IW-3718 Investigator
Hollywood, Florida, United States
IW-3718 Investigator
Inverness, Florida, United States
IW-3718 Investigator
Jupiter, Florida, United States
IW-3718 Investigator
Lauderdale Lakes, Florida, United States
IW-3718 Investigator
Miami, Florida, United States
IW-3718 Investigator
Miami, Florida, United States
IW-3718 Investigator
Miami Lakes, Florida, United States
IW-3718 Investigator
Port Orange, Florida, United States
IW-3718 Investigator
Clive, Iowa, United States
IW-3718 Investigator
Bowling Green, Kentucky, United States
IW-3718 Investigator
Monroe, Louisiana, United States
IW-3718 Investigator
Annapolis, Maryland, United States
IW-3718 Investigator
Baltimore, Maryland, United States
IW-3718 Investigator
Chevy Chase, Maryland, United States
IW-3718 Investigator
Chesterfield, Michigan, United States
IW-3718 Investigator
Wyoming, Michigan, United States
IW-3718 Investigator
Las Vegas, Nevada, United States
IW-3718 Investigator
Reno, Nevada, United States
IW-3718 Investigator
Egg Harbor, New Jersey, United States
IW-3718 Investigator
Great Neck, New York, United States
IW-3718 Investigator
Great Neck, New York, United States
IW-3718 Investigator
Kew Gardens, New York, United States
IW-3718 Investigator
New York, New York, United States
IW-3718 Investigator
Asheville, North Carolina, United States
IW-3718 Investigator
Raleigh, North Carolina, United States
IW-3718 Investigator
Fargo, North Dakota, United States
IW-3718 Investigator
Cleveland, Ohio, United States
IW-3718 Investigator
Columbus, Ohio, United States
IW-3718 Investigator
Lima, Ohio, United States
IW-3718 Investigator
Norman, Oklahoma, United States
IW-3718 Investigator
Oklahoma City, Oklahoma, United States
IW-3718 Investigator
Pittsburgh, Pennsylvania, United States
IW-3718 Investigator
Charleston, South Carolina, United States
IW-3718 Investigator
Chattanooga, Tennessee, United States
IW-3718 Investigator
Germantown, Tennessee, United States
IW-3718 Investigator
Nashville, Tennessee, United States
IW-3718 Investigator
El Paso, Texas, United States
IW-3718 Investigator
Houston, Texas, United States
IW-3718 Investigator
San Antonio, Texas, United States
IW-3718 Investigator
San Antonio, Texas, United States
IW-3718 Investigator
Sandy City, Utah, United States
IW-3718 Investigator
South Ogden, Utah, United States
IW-3718 Investigator
Christiansburg, Virginia, United States
IW-3718 Investigator
Lynchburg, Virginia, United States
Countries
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References
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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.
Andrae 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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ICP-3718-202
Identifier Type: -
Identifier Source: org_study_id
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