A Randomized, Double-blind, Placebo-controlled,Trial of IW-3718 for 8 Weeks in Patient With Symptomatic GERD



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/4/2017
Start Date:March 2016
End Date:April 2017

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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 GERD That Persists Despite Treatment With Proton Pump Inhibitors

The objectives of this study are to evaluate the safety, efficacy, and dose-response
relationship of IW-3718 administered orally to patients who have GERD and continue to
experience GERD symptoms while receiving once-daily (QD), standard-dose PPIs

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group,
8-week study, consisting of 3 distinct periods: a screening period, pretreatment period, and
treatment period. The study will enroll patients who have GERD and continue to experience
GERD symptoms while receiving QD, standard-dose PPI therapy. Eligible patients will continue
to take their PPI and will be randomized to placebo or to one of three doses of study drug.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).
We found this trial at
65
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South Ogden, Utah 84405
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Anaheim, California 92801
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Annapolis, Maryland 21401
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Asheville, North Carolina 28801
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Baltimore, Maryland 21215
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Birmingham, Alabama 35216
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Boston, Massachusetts 02215
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Bowling Green, Kentucky 42101
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Bristol, Connecticut 06010
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Carmichael, California 95608
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Charleston, South Carolina 29425
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48097
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Chevy Chase, Maryland 20815
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Christiansburg, Virginia 24073
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Chula Vista, California 91910
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Cleveland, Ohio 44109
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Clive, Iowa 50325
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Columbus, Ohio 43213
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DeLand, Florida 32720
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410 Alabama 1
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410 Egg Harbor Road
Egg Harbor City, New Jersey 08234
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El Paso, Texas 79905
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Encinitas, California 92024
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Fargo, North Dakota 58103
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Germantown, Tennessee 38138
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Great Neck, New York 11021
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Greensboro, North Carolina 27403
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Harlingen, Texas 78550
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Hollywood, Florida 33024
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Houston, Texas 77098
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Inverness, Florida 34452
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Jackson, Mississippi 39202
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Jupiter, Florida 33458
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Kew Gardens, New York 11415
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La Mirada, California 90638
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Las Vegas, Nevada 89128
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Lauderdale Lakes, Florida 33319
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Lima, Ohio 45806
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Lynchburg, Virginia 24502
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Miami, Florida 33126
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Miami Lakes, Florida 33014
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Mission Hills, California 91345
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Monroe, Louisiana 71201
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Nashville, Tennessee 37205
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New York, New York 10065
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Newport Beach, California 92660
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Norman, Oklahoma 73071
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North Little Rock, Arkansas 72117
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Port Orange, Florida 32129
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Raleigh, North Carolina 27612
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Reno, Nevada 89511
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Sacramento, California 95821
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San Diego, California 92123
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Tucson, Arizona 85710
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Waterbury, Connecticut 06708
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Wyoming, Michigan 49519
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