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

Use our guide to learn which trials are right for you!

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
sites
Great Neck, New York 11021
Phone: 516-482-5976
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Anaheim, California 92801
Phone: 714-774-7777
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Annapolis, Maryland 21401
Phone: 317-297-2208
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Asheville, North Carolina 28801
Phone: 828-254-0881
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Baltimore, Maryland 21215
Phone: 410-601-8256
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35216
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bowling Green, Kentucky 42101
Phone: 270-781-5111
?
mi
from
Bowling Green, KY
Click here to add this to my saved trials
Bristol, Connecticut 06010
Phone: 860-585-3838
?
mi
from
Bristol, CT
Click here to add this to my saved trials
Carmichael, California 95608
Phone: 208-377-8653
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
Charleston, South Carolina 29425
Phone: 843-792-0644
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Phone: 423-698-4584
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Michigan 48097
Phone: 586-598-3329
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
Phone: 202-296-3449
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Christiansburg, Virginia 24073
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Chula Vista, California 91910
Phone: 619-585-8882
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cleveland, Ohio 44109
Phone: 216-957-6488
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clive, Iowa 50325
Phone: 515-225-1035
?
mi
from
Clive, IA
Click here to add this to my saved trials
Columbus, Ohio 43213
Phone: 614-501-6164
?
mi
from
Columbus, OH
Click here to add this to my saved trials
DeLand, Florida 32720
Phone: 386-740-0770
?
mi
from
DeLand, FL
Click here to add this to my saved trials
410 Alabama 1
Dothan, Alabama 36305
Phone: 334-836-1055
?
mi
from
Dothan, AL
Click here to add this to my saved trials
410 Egg Harbor Road
Egg Harbor City, New Jersey 08234
?
mi
from
Egg Harbor City, NJ
Click here to add this to my saved trials
El Paso, Texas 79905
Phone: 915-545-6857
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Encinitas, California 92024
Phone: 760-274-2704
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Fargo, North Dakota 58103
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Greensboro, North Carolina 27403
Phone: 336-547-1739
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Harlingen, Texas 78550
Phone: 956-365-4400
?
mi
from
Harlingen, TX
Click here to add this to my saved trials
Hollywood, Florida 33024
Phone: 954-435-9990
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77098
Phone: 877-399-0254
?
mi
from
Houston, TX
Click here to add this to my saved trials
Inverness, Florida 34452
Phone: 352-341-2100
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jackson, Mississippi 39202
Phone: 601-863-0395
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jupiter, Florida 33458
Phone: 561-741-2033
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
Kew Gardens, New York 11415
Phone: 866-879-2507
?
mi
from
Kew Gardens, NY
Click here to add this to my saved trials
La Mirada, California 90638
Phone: 817-282-8045
?
mi
from
La Mirada, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Phone: 702-385-0046
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33319
Phone: 817-282-8045
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lima, Ohio 45806
Phone: 419-879-8627
?
mi
from
Lima, OH
Click here to add this to my saved trials
Lynchburg, Virginia 24502
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33126
Phone: 305-400-0814
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Mission Hills, California 91345
Phone: 818-838-3576
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
Monroe, Louisiana 71201
Phone: 318-807-0819
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Nashville, Tennessee 37205
Phone: 615-936-5795
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10065
Phone: 646-660-4006
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
Phone: 562-861-5600
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Norman, Oklahoma 73071
Phone: 405-329-0474
?
mi
from
Norman, OK
Click here to add this to my saved trials
North Little Rock, Arkansas 72117
Phone: 501-945-9300
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Oakland, California 64612
Phone: 510-444-4056
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Phone: 405-271-2619
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Phone: 215-662-3049
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85018
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15243
Phone: 412-942-0010
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Port Orange, Florida 32129
Phone: 386-760-7092
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27612
Phone: 919-781-2514
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Reno, Nevada 89511
Phone: 801-409-0240
?
mi
from
Reno, NV
Click here to add this to my saved trials
Sacramento, California 95821
Phone: 916-484-0500
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78229
Phone: 210-615-8308
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
Phone: 858-277-5678
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sandy City, Utah 84092
?
mi
from
Sandy City, UT
Click here to add this to my saved trials
Shreveport, Louisiana 71103
Phone: 318-525-3226
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
South Ogden, Utah 84405
Phone: 801-409-0240
?
mi
from
South Ogden, UT
Click here to add this to my saved trials
Tucson, Arizona 85710
Phone: 520-382-1166
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Waterbury, Connecticut 06708
Phone: 203-419-4420
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Wyoming, Michigan 49519
Phone: 231-727-4369
?
mi
from
Wyoming, MI
Click here to add this to my saved trials