Clinical trial NCT00630370: A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post Prandial Distress Syndrome
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
Collaborators: name: ARYx Therapeutics
First posted: 2008-03-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
timeFrame: Day 42
Secondary outcomes:
measure: Safety and tolerability of ATI 7505
timeFrame: 42 days
measure: Time to recurrence of the 2 primary PDS symptoms at day 42
timeFrame: 42 days
measure: Effect of ATI 7505 treatment on quality of life indices
timeFrame: 42 days
Other outcomes:
Locations:
city: Chino
country: United States
facility: Research Facility
state: California
city: Fresno
country: United States
facility: Research Facility
state: California
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: Mission Viejo
country: United States
facility: Research Facility
state: California
city: San Carlos
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: Littleton
country: United States
facility: Research Facility
state: Colorado
city: Boynton Beach
country: United States
facility: Research Facility
state: Florida
city: Deland
country: United States
facility: Research Facility
state: Florida
city: Hollywood
country: United States
facility: Research Facility
state: Florida
city: Jacksonville
country: United States
facility: Research Facility
state: Florida
city: Largo
country: United States
facility: Research Facility
state: Florida
city: Miami
country: United States
facility: Research Facility
state: Florida
city: New Port Richey
country: United States
facility: Research Facility
state: Florida
city: Orlando
country: United States
facility: Research Facility
state: Florida
city: Newman
country: United States
facility: Research Facility
state: Georgia
city: Savannah
country: United States
facility: Research Facility
state: Georgia
city: Rockford
country: United States
facility: Research Facility
state: Illinois
city: Evansville
country: United States
facility: Research Facility
state: Indiana
city: Topeka
country: United States
facility: Research Facility
state: Kansas
city: Monroe
country: United States
facility: Research Facility
state: Louisiana
city: Detroit
country: United States
facility: Research Facility
state: Michigan
city: Brooklyn
country: United States
facility: Research Facility
state: New York
city: Great Neck
country: United States
facility: Research Facility
state: New York
city: Great Neck
country: United States
facility: Research Facility
state: New York
city: Lake Success
country: United States
facility: Research Facility
state: New York
city: Syracuse
country: United States
facility: Research Facility
state: New York
city: Fayetteville
country: United States
facility: Research Facility
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Facility
state: North Carolina
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Dayton
country: United States
facility: Research Facility
state: Ohio
city: Oklahoma City
country: United States
facility: Research Facility
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Facility
state: Oklahoma
city: Ashland
country: United States
facility: Research Facility
state: Oregon
city: Beaver Falls
country: United States
facility: Research Facility
state: Pennsylvania
city: Anderson
country: United States
facility: Research Facility
state: South Carolina
city: Charleston
country: United States
facility: Research Facility
state: South Carolina
city: Chattanooga
country: United States
facility: Research Facility
state: Tennessee
city: Chattanooga
country: United States
facility: Research Facility
state: Tennessee
city: Colleyville
country: United States
facility: Research Facility
state: Texas
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: Winchester
country: United States
facility: Research Facility
state: Virginia
city: Milwaukee
country: United States
facility: Research Facility
state: Wisconsin
city: Guelph
country: Canada
facility: Research Facility
city: Hamilton
country: Canada
facility: Research Facility
city: Hamilton
country: Canada
facility: Research Facility
city: Levis
country: Canada
facility: Research Facility
city: Longueuil
country: Canada
facility: Research Facility
city: Montreal
country: Canada
facility: Research Facility
city: Ottawa
country: Canada
facility: Research Facility
city: Quebec
country: Canada
facility: Research Facility
city: Quebec
country: Canada
facility: Research Facility
city: Quebec
country: Canada
facility: Research Facility
city: St. Charles Borromee
country: Canada
facility: Research Facility
city: Toronto
country: Canada
facility: Research Facility
city: Birmingham
country: United Kingdom
facility: Research Facility
city: Cardiff
country: United Kingdom
facility: Research Facility
city: Coventry
country: United Kingdom
facility: Research Facility
city: Crewe
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: Norwich
country: United Kingdom
facility: Research Facility
city: Orpington
country: United Kingdom
facility: Research Facility
city: Salford
country: United Kingdom
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Bruce C Yacyshyn, MD
role: STUDY_DIRECTOR
References: