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

Tracking Information

First Received Date ^ICMJE

February 28, 2008

Last Updated Date

June 16, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00630370 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Post Prandial Distress Syndrome

Intervention ^ICMJE

Drug: Placebo
2 Placebo tablets, TID, orally, 58 days
Drug: 20 mg ATI 7505
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
Drug: 40 mg ATI 7505
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
Drug: 80 mg ATI 7505
2 ATI 40mg tablets, TID, orally, 58 days

Study Arms

Placebo Comparator: 1
2 Placebo tablets, TID, orally, 58 days

Intervention: Drug: Placebo
Experimental: 2
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days

Intervention: Drug: 20 mg ATI 7505
Experimental: 3
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days

Intervention: Drug: 40 mg ATI 7505
Experimental: 4
2 ATI 40mg tablets, TID, orally, 58 days

Intervention: Drug: 80 mg ATI 7505

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00630370

Other Study ID Numbers ^ICMJE

2007033

Has Data Monitoring Committee

Responsible Party

Bruce Yacyshyn, MD, Procter & Gamble

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

ARYx Therapeutics

Investigators ^ICMJE

Study Director:

Bruce C Yacyshyn, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP