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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
2 Placebo tablets, TID, orally, 58 days
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
Time frame: Day 42
Safety and tolerability of ATI 7505
Time frame: 42 days
Time to recurrence of the 2 primary PDS symptoms at day 42
Time frame: 42 days
Effect of ATI 7505 treatment on quality of life indices
Time frame: 42 days
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2 ATI 40mg tablets, TID, orally, 58 days
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Chino, California, United States
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