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

This study has been terminated.
Sponsor:
Collaborator:
ARYx Therapeutics
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00630370
First received: February 28, 2008
Last updated: June 16, 2009
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Post Prandial Distress Syndrome
Drug: Placebo
Drug: 20 mg ATI 7505
Drug: 40 mg ATI 7505
Drug: 80 mg ATI 7505
Phase 2

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

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS. [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of ATI 7505 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Time to recurrence of the 2 primary PDS symptoms at day 42 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Effect of ATI 7505 treatment on quality of life indices [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630370

  Show 64 Study Locations
Sponsors and Collaborators
Procter and Gamble
ARYx Therapeutics
Investigators
Study Director: Bruce C Yacyshyn, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Bruce Yacyshyn, MD, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00630370     History of Changes
Other Study ID Numbers: 2007033
Study First Received: February 28, 2008
Last Updated: June 16, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014