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 |
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
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.
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
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