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

June 16, 2009 updated by: Procter and Gamble

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Guelph, Canada, N1H 3R3
        • Research Facility
      • Hamilton, Canada, L8N 3Z5
        • Research Facility
      • Hamilton, Canada, L8N 4A6
        • Research Facility
      • Levis, Canada, G6V 3Z1
        • Research Facility
      • Longueuil, Canada, J4N 1E1
        • Research Facility
      • Montreal, Canada, H1T 2M4
        • Research Facility
      • Ottawa, Canada, K1H 8L6
        • Research Facility
      • Quebec, Canada, G1L 3L5
        • Research Facility
      • Quebec, Canada, G1R 2J6
        • Research Facility
      • Quebec, Canada, G1S 4L8
        • Research Facility
      • St. Charles Borromee, Canada, J6E 6J2
        • Research Facility
      • Toronto, Canada, M3N 2V7
        • Research Facility
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Research Facility
      • Cardiff, United Kingdom, CF14 4XW
        • Research Facility
      • Coventry, United Kingdom, CV2 2DX
        • Research Facility
      • Crewe, United Kingdom, CW1 4QJ
        • Research Facility
      • London, United Kingdom, NW3 2QG
        • Research Facility
      • Norwich, United Kingdom, NR4 7UY
        • Research Facility
      • Orpington, United Kingdom, BR6 8ND
        • Research Facility
      • Salford, United Kingdom, M6 8HD
        • Research Facility
  • United States
    • California
      • Chino, California, United States, 91710
        • Research Facility
      • Fresno, California, United States, 93721
        • Research Facility
      • Los Angeles, California, United States, 90015
        • Research Facility
      • Los Angeles, California, United States, 90045
        • Research Facility
      • Mission Viejo, California, United States, 92691
        • Research Facility
      • San Carlos, California, United States, 94070
        • Research Facility
      • San Diego, California, United States, 92108
        • Research Facility
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Research Facility
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Research Facility
      • Deland, Florida, United States, 32720
        • Research Facility
      • Hollywood, Florida, United States, 33021
        • Research Facility
      • Jacksonville, Florida, United States, 32256
        • Research Facility
      • Largo, Florida, United States, 33777
        • Research Facility
      • Miami, Florida, United States, 33156
        • Research Facility
      • New Port Richey, Florida, United States, 34652
        • Research Facility
      • Orlando, Florida, United States, 32806
        • Research Facility
    • Georgia
      • Newman, Georgia, United States, 30263
        • Research Facility
      • Savannah, Georgia, United States, 31405
        • Research Facility
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Research Facility
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Research Facility
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Research Facility
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Research Facility
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Research Facility
    • New York
      • Brooklyn, New York, United States, 11214
        • Research Facility
      • Great Neck, New York, United States, 11021
        • Research Facility
      • Great Neck, New York, United States, 11023
        • Research Facility
      • Lake Success, New York, United States, 11042
        • Research Facility
      • Syracuse, New York, United States, 13210
        • Research Facility
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Research Facility
      • Winston-Salem, North Carolina, United States, 27103
        • Research Facility
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Facility
      • Dayton, Ohio, United States, 45440
        • Research Facility
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Facility
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Facility
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Research Facility
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States, 15010
        • Research Facility
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Facility
      • Charleston, South Carolina, United States, 29414
        • Research Facility
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Research Facility
      • Chattanooga, Tennessee, United States, 37404
        • Research Facility
    • Texas
      • Colleyville, Texas, United States, 76034
        • Research Facility
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Research Facility
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Research Facility
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
2 Placebo tablets, TID, orally, 58 days
Drug: Placebo
2 Placebo tablets, TID, orally, 58 days
Experimental: 2
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
Experimental: 3
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
Experimental: 4
2 ATI 40mg tablets, TID, orally, 58 days
Drug: 80 mg ATI 7505
2 ATI 40mg tablets, TID, orally, 58 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
Time Frame: Day 42
Day 42

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Collaborators

ARYx Therapeutics

Investigators

  • Study Director: Bruce C Yacyshyn, MD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 16, 2009

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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