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

Primary Purpose

Post Prandial Distress Syndrome

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
20 mg ATI 7505
40 mg ATI 7505
80 mg ATI 7505
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Prandial Distress Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

2 Placebo tablets, TID, orally, 58 days

1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days

1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days

2 ATI 40mg tablets, TID, orally, 58 days

Outcomes

Primary Outcome Measures

Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.

Secondary Outcome Measures

Safety and tolerability of ATI 7505
Time to recurrence of the 2 primary PDS symptoms at day 42
Effect of ATI 7505 treatment on quality of life indices

Full Information

First Posted
February 28, 2008
Last Updated
June 16, 2009
Sponsor
Procter and Gamble
Collaborators
ARYx Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00630370
Brief Title
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

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Procter and Gamble
Collaborators
ARYx Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Prandial Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
2 Placebo tablets, TID, orally, 58 days
Arm Title
2
Arm Type
Experimental
Arm Description
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
Arm Title
3
Arm Type
Experimental
Arm Description
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
Arm Title
4
Arm Type
Experimental
Arm Description
2 ATI 40mg tablets, TID, orally, 58 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 Placebo tablets, TID, orally, 58 days
Intervention Type
Drug
Intervention Name(s)
20 mg ATI 7505
Intervention Description
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
Intervention Type
Drug
Intervention Name(s)
40 mg ATI 7505
Intervention Description
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
Intervention Type
Drug
Intervention Name(s)
80 mg ATI 7505
Intervention Description
2 ATI 40mg tablets, TID, orally, 58 days
Primary Outcome Measure Information:
Title
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
Safety and tolerability of ATI 7505
Time Frame
42 days
Title
Time to recurrence of the 2 primary PDS symptoms at day 42
Time Frame
42 days
Title
Effect of ATI 7505 treatment on quality of life indices
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce C Yacyshyn, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Research Facility
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Research Facility
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Research Facility
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Research Facility
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Research Facility
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
Research Facility
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Facility
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Research Facility
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Research Facility
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Facility
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Research Facility
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research Facility
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Research Facility
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Research Facility
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Research Facility
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Facility
City
Newman
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Research Facility
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Research Facility
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Research Facility
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Research Facility
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Research Facility
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Research Facility
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Research Facility
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Research Facility
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Research Facility
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Facility
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Research Facility
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Research Facility
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Research Facility
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Facility
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Research Facility
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Facility
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Facility
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Research Facility
City
Beaver Falls
State/Province
Pennsylvania
ZIP/Postal Code
15010
Country
United States
Facility Name
Research Facility
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Facility
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Research Facility
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Research Facility
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Research Facility
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Research Facility
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Research Facility
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Research Facility
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Research Facility
City
Guelph
ZIP/Postal Code
N1H 3R3
Country
Canada
Facility Name
Research Facility
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Research Facility
City
Hamilton
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Research Facility
City
Levis
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Research Facility
City
Longueuil
ZIP/Postal Code
J4N 1E1
Country
Canada
Facility Name
Research Facility
City
Montreal
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Facility
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Facility
City
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada
Facility Name
Research Facility
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Research Facility
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Research Facility
City
St. Charles Borromee
ZIP/Postal Code
J6E 6J2
Country
Canada
Facility Name
Research Facility
City
Toronto
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Research Facility
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Research Facility
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Research Facility
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Research Facility
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Facility
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Research Facility
City
Orpington
ZIP/Postal Code
BR6 8ND
Country
United Kingdom
Facility Name
Research Facility
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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