A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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).

Key facts

Study ID

NCT02637557

Run by

Ironwood Pharmaceuticals, Inc.

People needed

282

Starts

2016-03-01

Expected to finish

2017-04-26

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• NOTE: Additional inclusion/exclusion criteria may apply.

Where it is running

• 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 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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