Post Prandial Distress Syndrome
Conditions
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.
Interventions
DRUGPlacebo
2 Placebo tablets, TID, orally, 58 days
DRUG20 mg ATI 7505
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
DRUG40 mg ATI 7505
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
DRUG80 mg ATI 7505
2 ATI 40mg tablets, TID, orally, 58 days
Sponsors
ARYx Therapeutics
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS. | Day 42 |
Secondary
| Measure | 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 |
Countries
Canada, United Kingdom, United States
Outcome results
None listed