A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.

Official Title
-----------------
A Phase II, Randomized, Adaptive Design, Multicenter, Parallel Group, Placebo-Controlled, 58 Day, Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome

Conditions
-----------------
Post Prandial Distress Syndrome

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: 20 mg ATI 7505
* Drug: 40 mg ATI 7505
* Drug: 80 mg ATI 7505


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Were diagnosed with PDS at least 6 months prior to screening, OR had onset of 2 or more PDS symptoms at least 6 months prior to screening. Experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening. Had a normal upper GI endoscopy within the past year. Exclusion Criteria: Heartburn that occurs >3 times per week Current Helicobacter pylori (H pylori) infection confirmed by stool sample testing or breath testing, or H pylori eradication therapy within the 6 months prior to screening Any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening At screening, a QT interval corrected for heart rate using Bazett's correction formula (QTcB) >440 msec as determined by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>2 Placebo tablets, TID, orally, 58 days | Drug: Placebo<br>* 2 Placebo tablets, TID, orally, 58 days<br>|
| Experimental: 2<br>1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days | Drug: 20 mg ATI 7505<br>* 1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days<br>|
| Experimental: 3<br>1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days | Drug: 40 mg ATI 7505<br>* 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days<br>|
| Experimental: 4<br>2 ATI 40mg tablets, TID, orally, 58 days | Drug: 80 mg ATI 7505<br>* 2 ATI 40mg tablets, TID, orally, 58 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS. |  | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ATI 7505 |  | 42 days | 
| Time to recurrence of the 2 primary PDS symptoms at day 42 |  | 42 days | 
| Effect of ATI 7505 treatment on quality of life indices |  | 42 days |