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

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

Conditions
-----------------
Dyspepsia, Functional Gastrointestinal Disorders

Intervention / Treatment
-----------------
* Drug: IW-9179
* Drug: Placebo


Participation Criteria
=================
Eligibility 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: Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-9179<br>Oral IW-9179 taken daily for two weeks | Drug: IW-9179<br> <br> |
| Placebo Comparator: Placebo<br>Oral placebo taken daily for two weeks | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment-emergent adverse events |  | Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up | 
| Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment |  | Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14) | 
| Change from baseline clinical laboratory evaluations at the last day of treatment (day 14) |  | Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14) | 
| Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose) |  | Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-meal Symptom Severity (PMSS) Assessment | Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose) | Completed at day 1 and day 14 of the Treatment Period | 
| Daily Patient Symptom Severity (PSS) Assessment | Assessments recorded on a daily basis | Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment | 
| Weekly Symptom Relief (SR) Assessments | Assessments recorded on a weekly basis weekly | Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment | 
| Nepean Dyspepsia Index |  | Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose) |