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

Ironwood Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Functional Gastrointestinal Disorders; Dyspepsia

Treatments: Drug: Placebo; Drug: IW-9179

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712412

ICP-112-201

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

10 participants in 2 patient groups, including a placebo group

IW-9179

Experimental group

Description:

Oral IW-9179 taken daily for two weeks

Treatment:

Drug: IW-9179

Placebo

Placebo Comparator group

Description:

Oral placebo taken daily for two weeks

Treatment:

Drug: Placebo