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
1 other identifier
interventional
6
3 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJune 17, 2009
December 1, 2008
5 months
February 28, 2008
June 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
Day 42
Secondary Outcomes (3)
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
Study Arms (4)
1
PLACEBO COMPARATOR2 Placebo tablets, TID, orally, 58 days
2
EXPERIMENTAL1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
3
EXPERIMENTAL1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
4
EXPERIMENTAL2 ATI 40mg tablets, TID, orally, 58 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Procter and Gamblelead
- ARYx Therapeuticscollaborator
Study Sites (64)
Research Facility
Chino, California, 91710, United States
Research Facility
Fresno, California, 93721, United States
Research Facility
Los Angeles, California, 90015, United States
Research Facility
Los Angeles, California, 90045, United States
Research Facility
Mission Viejo, California, 92691, United States
Research Facility
San Carlos, California, 94070, United States
Research Facility
San Diego, California, 92108, United States
Research Facility
Littleton, Colorado, 80120, United States
Research Facility
Boynton Beach, Florida, 33426, United States
Research Facility
DeLand, Florida, 32720, United States
Research Facility
Hollywood, Florida, 33021, United States
Research Facility
Jacksonville, Florida, 32256, United States
Research Facility
Largo, Florida, 33777, United States
Research Facility
Miami, Florida, 33156, United States
Research Facility
New Port Richey, Florida, 34652, United States
Research Facility
Orlando, Florida, 32806, United States
Research Facility
Newnan, Georgia, 30263, United States
Research Facility
Savannah, Georgia, 31405, United States
Research Facility
Rockford, Illinois, 61107, United States
Research Facility
Evansville, Indiana, 47714, United States
Research Facility
Topeka, Kansas, 66606, United States
Research Facility
Monroe, Louisiana, 71201, United States
Research Facility
Detroit, Michigan, 48235, United States
Research Facility
Brooklyn, New York, 11214, United States
Research Facility
Great Neck, New York, 11021, United States
Research Facility
Great Neck, New York, 11023, United States
Research Facility
Lake Success, New York, 11042, United States
Research Facility
Syracuse, New York, 13210, United States
Research Facility
Fayetteville, North Carolina, 28304, United States
Research Facility
Winston-Salem, North Carolina, 27103, United States
Research Facility
Cincinnati, Ohio, 45242, United States
Research Facility
Dayton, Ohio, 45440, United States
Research Facility
Oklahoma City, Oklahoma, 73104, United States
Research Facility
Oklahoma City, Oklahoma, 73112, United States
Research Facility
Ashland, Oregon, 97520, United States
Research Facility
Beaver Falls, Pennsylvania, 15010, United States
Research Facility
Anderson, South Carolina, 29621, United States
Research Facility
Charleston, South Carolina, 29414, United States
Research Facility
Chattanooga, Tennessee, 37403, United States
Research Facility
Chattanooga, Tennessee, 37404, United States
Research Facility
Colleyville, Texas, 76034, United States
Research Facility
Salt Lake City, Utah, 84124, United States
Research Facility
Winchester, Virginia, 22601, United States
Research Facility
Milwaukee, Wisconsin, 53209, United States
Research Facility
Guelph, N1H 3R3, Canada
Research Facility
Hamilton, L8N 3Z5, Canada
Research Facility
Hamilton, L8N 4A6, Canada
Research Facility
Lévis, G6V 3Z1, Canada
Research Facility
Longueuil, J4N 1E1, Canada
Research Facility
Montreal, H1T 2M4, Canada
Research Facility
Ottawa, K1H 8L6, Canada
Research Facility
Québec, G1L 3L5, Canada
Research Facility
Québec, G1R 2J6, Canada
Research Facility
Québec, G1S 4L8, Canada
Research Facility
Saint-Charles-Borromée, J6E 6J2, Canada
Research Facility
Toronto, M3N 2V7, Canada
Research Facility
Birmingham, B9 5SS, United Kingdom
Research Facility
Cardiff, CF14 4XW, United Kingdom
Research Facility
Coventry, CV2 2DX, United Kingdom
Research Facility
Crewe, CW1 4QJ, United Kingdom
Research Facility
London, NW3 2QG, United Kingdom
Research Facility
Norwich, NR4 7UY, United Kingdom
Research Facility
Orpington, BR6 8ND, United Kingdom
Research Facility
Salford, M6 8HD, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bruce C Yacyshyn, MD
Procter and Gamble
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
February 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 17, 2009
Record last verified: 2008-12