Trials / Terminated
TerminatedNCT00630370
A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Procter and Gamble · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | 2 Placebo tablets, TID, orally, 58 days |
| DRUG | 20 mg ATI 7505 | 1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days |
| DRUG | 40 mg ATI 7505 | 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days |
| DRUG | 80 mg ATI 7505 | 2 ATI 40mg tablets, TID, orally, 58 days |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2008-03-07
- Last updated
- 2009-06-17
Locations
64 sites across 3 countries: United States, Canada, United Kingdom
Source: ClinicalTrials.gov record NCT00630370. Inclusion in this directory is not an endorsement.