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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: IW-3718; Drug: PPI; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02637557

ICP-3718-202

Details and patient eligibility

About

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).

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

NOTE: Additional inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Matching placebo twice daily

Treatment:

Drug: Matching Placebo

Drug: PPI

500 mg IW-3718

Experimental group

Description:

500 mg IW-3718 twice daily

Treatment:

Drug: IW-3718

Drug: PPI

1000 mg IW-3718

Experimental group

Description:

1000 mg IW-3718 twice daily

Treatment:

Drug: IW-3718

Drug: PPI

1500 mg IW-3718

Experimental group

Description:

1500 mg IW-3718 twice daily

Treatment:

Drug: IW-3718

Drug: PPI