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

Post Prandial Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00630370
• Other study ID #: 2007033
• Status: Terminated
• Phase: Phase 2
• First received: February 28, 2008
• Last updated: June 16, 2009
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2008
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Prandial Distress Syndrome
• Syndrome

Intervention

Drug:
• Placebo
2 Placebo tablets, TID, orally, 58 days
• 20 mg ATI 7505
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
• 40 mg ATI 7505
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
• 80 mg ATI 7505
2 ATI 40mg tablets, TID, orally, 58 days

Locations

Country	Name	City	State
Canada	Research Facility	Guelph
Canada	Research Facility	Hamilton
Canada	Research Facility	Hamilton
Canada	Research Facility	Levis
Canada	Research Facility	Longueuil
Canada	Research Facility	Montreal
Canada	Research Facility	Ottawa
Canada	Research Facility	Quebec
Canada	Research Facility	Quebec
Canada	Research Facility	Quebec
Canada	Research Facility	St. Charles Borromee
Canada	Research Facility	Toronto
United Kingdom	Research Facility	Birmingham
United Kingdom	Research Facility	Cardiff
United Kingdom	Research Facility	Coventry
United Kingdom	Research Facility	Crewe
United Kingdom	Research Facility	London
United Kingdom	Research Facility	Norwich
United Kingdom	Research Facility	Orpington
United Kingdom	Research Facility	Salford
United States	Research Facility	Anderson	South Carolina
United States	Research Facility	Ashland	Oregon
United States	Research Facility	Beaver Falls	Pennsylvania
United States	Research Facility	Boynton Beach	Florida
United States	Research Facility	Brooklyn	New York
United States	Research Facility	Charleston	South Carolina
United States	Research Facility	Chattanooga	Tennessee
United States	Research Facility	Chattanooga	Tennessee
United States	Research Facility	Chino	California
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Colleyville	Texas
United States	Research Facility	Dayton	Ohio
United States	Research Facility	Deland	Florida
United States	Research Facility	Detroit	Michigan
United States	Research Facility	Evansville	Indiana
United States	Research Facility	Fayetteville	North Carolina
United States	Research Facility	Fresno	California
United States	Research Facility	Great Neck	New York
United States	Research Facility	Great Neck	New York
United States	Research Facility	Hollywood	Florida
United States	Research Facility	Jacksonville	Florida
United States	Research Facility	Lake Success	New York
United States	Research Facility	Largo	Florida
United States	Research Facility	Littleton	Colorado
United States	Research Facility	Los Angeles	California
United States	Research Facility	Los Angeles	California
United States	Research Facility	Miami	Florida
United States	Research Facility	Milwaukee	Wisconsin
United States	Research Facility	Mission Viejo	California
United States	Research Facility	Monroe	Louisiana
United States	Research Facility	New Port Richey	Florida
United States	Research Facility	Newman	Georgia
United States	Research Facility	Oklahoma City	Oklahoma
United States	Research Facility	Oklahoma City	Oklahoma
United States	Research Facility	Orlando	Florida
United States	Research Facility	Rockford	Illinois
United States	Research Facility	Salt Lake City	Utah
United States	Research Facility	San Carlos	California
United States	Research Facility	San Diego	California
United States	Research Facility	Savannah	Georgia
United States	Research Facility	Syracuse	New York
United States	Research Facility	Topeka	Kansas
United States	Research Facility	Winchester	Virginia
United States	Research Facility	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Procter and Gamble	ARYx Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.		Day 42	No
Secondary	Safety and tolerability of ATI 7505		42 days	No
Secondary	Time to recurrence of the 2 primary PDS symptoms at day 42		42 days	No
Secondary	Effect of ATI 7505 treatment on quality of life indices		42 days	No