Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Patient meets ROME III criteria for functional dyspepsia (FD)

• Patient has a normal esophagogastroduodenoscopy (EGD) either during the Screening Period or within 2 years of the Screening Visit

• Patients who EITHER:

1. Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR

2. Have used a PPI at a stable dose for at least 4 weeks prior to the Screening Visit;

• Patient meets symptom severity criteria in the Pretreatment Period

• Patient is fluent and literate in Dutch, French, or English

Exclusion Criteria:

• Patient meets criteria for gastroesophageal reflux disease (GERD, stable regimen of PPIs acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis

• Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma

• Any significant neurological disease or a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable; complete remission of other cancers for 5 years or longer is also acceptable)

• History of active alcoholism or drug addiction within 12 months prior to the Screening Visit

• Hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the Screening Visit

• Any organic or structural disease that can cause abdominal pain or discomfort