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

Sponsors and Collaborators:	Procter and Gamble ARYx Therapeutics
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00630370

Purpose

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.

Condition	Intervention	Phase
Post Prandial Distress Syndrome	Drug: Placebo Drug: 20 mg ATI 7505 Drug: 40 mg ATI 7505 Drug: 80 mg ATI 7505	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS. [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of ATI 7505 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Time to recurrence of the 2 primary PDS symptoms at day 42 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Effect of ATI 7505 treatment on quality of life indices [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 2 Placebo tablets, TID, orally, 58 days	Drug: Placebo 2 Placebo tablets, TID, orally, 58 days
2: Experimental 1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days	Drug: 20 mg ATI 7505 1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
3: Experimental 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days	Drug: 40 mg ATI 7505 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
4: Experimental 2 ATI 40mg tablets, TID, orally, 58 days	Drug: 80 mg ATI 7505 2 ATI 40mg tablets, TID, orally, 58 days

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630370

Show 64 Study Locations

Sponsors and Collaborators

Procter and Gamble

ARYx Therapeutics

Investigators

Study Director:

Bruce C Yacyshyn, MD

Procter and Gamble

More Information

Responsible Party:	Procter & Gamble ( Bruce Yacyshyn, MD )
Study ID Numbers:	2007033
Study First Received:	February 28, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00630370
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009