Post Prandial Distress SyndromePhase 2NCT00630370
A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome
A Phase 2 study testing 20 mg ATI 7505, 40 mg ATI 7505 and 80 mg ATI 7505 in people with Post Prandial Distress Syndrome, run by Procter and Gamble at 64 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Prandial Distress Syndrome
- What is being tested?
- 20 mg ATI 7505, 40 mg ATI 7505 and 80 mg ATI 7505
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 64 sitesin 3 countries
- Study dates
- Feb 2008to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
64 sites in 3 countries.
64 sites in 3 countries
United States44 sites
Research Facility
Anderson, South Carolina, 29621
Research Facility
Ashland, Oregon, 97520
Research Facility
Beaver Falls, Pennsylvania, 15010
Research Facility
Boynton Beach, Florida, 33426
Research Facility
Brooklyn, New York, 11214
Research Facility
Charleston, South Carolina, 29414
Research Facility
Chattanooga, Tennessee, 37403
Research Facility
Chattanooga, Tennessee, 37404
Research Facility
Chino, California, 91710
Research Facility
Cincinnati, Ohio, 45242
Research Facility
Colleyville, Texas, 76034
Research Facility
Dayton, Ohio, 45440
Research Facility
DeLand, Florida, 32720
Research Facility
Detroit, Michigan, 48235
Research Facility
Evansville, Indiana, 47714
Research Facility
Fayetteville, North Carolina, 28304
Research Facility
Fresno, California, 93721
Research Facility
Great Neck, New York, 11021
Research Facility
Great Neck, New York, 11023
Research Facility
Hollywood, Florida, 33021
Research Facility
Jacksonville, Florida, 32256
Research Facility
Lake Success, New York, 11042
Research Facility
Largo, Florida, 33777
Research Facility
Littleton, Colorado, 80120
Research Facility
Los Angeles, California, 90015
Research Facility
Los Angeles, California, 90045
Research Facility
Miami, Florida, 33156
Research Facility
Milwaukee, Wisconsin, 53209
Research Facility
Mission Viejo, California, 92691
Research Facility
Monroe, Louisiana, 71201
Research Facility
New Port Richey, Florida, 34652
Research Facility
Newnan, Georgia, 30263
Research Facility
Oklahoma City, Oklahoma, 73104
Research Facility
Oklahoma City, Oklahoma, 73112
Research Facility
Orlando, Florida, 32806
Research Facility
Rockford, Illinois, 61107
Research Facility
Salt Lake City, Utah, 84124
Research Facility
San Carlos, California, 94070
Research Facility
San Diego, California, 92108
Research Facility
Savannah, Georgia, 31405
Research Facility
Syracuse, New York, 13210
Research Facility
Topeka, Kansas, 66606
Research Facility
Winchester, Virginia, 22601
Research Facility
Winston-Salem, North Carolina, 27103
Canada12 sites
Research Facility
Guelph, N1H 3R3
Research Facility
Hamilton, L8N 3Z5
Research Facility
Hamilton, L8N 4A6
Research Facility
Lévis, G6V 3Z1
Research Facility
Longueuil, J4N 1E1
Research Facility
Montreal, H1T 2M4
Research Facility
Ottawa, K1H 8L6
Research Facility
Québec, G1L 3L5
Research Facility
Québec, G1R 2J6
Research Facility
Québec, G1S 4L8
Research Facility
Saint-Charles-Borromée, J6E 6J2
Research Facility
Toronto, M3N 2V7
United Kingdom8 sites
Research Facility
Birmingham, B9 5SS
Research Facility
Cardiff, CF14 4XW
Research Facility
Coventry, CV2 2DX
Research Facility
Crewe, CW1 4QJ
Research Facility
London, NW3 2QG
Research Facility
Norwich, NR4 7UY
Research Facility
Orpington, BR6 8ND
Research Facility
Salford, M6 8HD
About this study
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
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.
- Conditions
- Post Prandial Distress Syndrome
- Being tested
- Placebo, 20 mg ATI 7505, 40 mg ATI 7505, 80 mg ATI 7505
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 Placebo tablets, TID, orally, 58 days
20 mg ATI 7505Drug
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
40 mg ATI 7505Drug
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
80 mg ATI 7505Drug
2 ATI 40mg tablets, TID, orally, 58 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 2 Placebo tablets, TID, orally, 58 days Receives: Drug: Placebo |
| 2 | Experimental | 1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days Receives: Drug: 20 mg ATI 7505 |
| 3 | Experimental | 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days Receives: Drug: 40 mg ATI 7505 |
| 4 | Experimental | 2 ATI 40mg tablets, TID, orally, 58 days Receives: Drug: 80 mg ATI 7505 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
Measured: Day 42
Secondary outcomes (3)
Safety and tolerability of ATI 7505
Measured: 42 days
Time to recurrence of the 2 primary PDS symptoms at day 42
Measured: 42 days
Effect of ATI 7505 treatment on quality of life indices
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Prandial Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ARYx Therapeutics
- Investigators
- Bruce C Yacyshyn, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630370
- Sponsor's protocol ID
- 2007033
- Status last verified
- Dec 2008
- First submitted
- 28 Feb 2008
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00630370
- Acronym / sponsor ID
- 2007033
- Conditions
- Post Prandial Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Collaborators
- ARYx Therapeutics
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo2 Placebo tablets, TID, orally, 58 days |
| 2 | Experimental | Drug: 20 mg ATI 75051 ATI 20mg and 1 placebo tablet, TID, orally, 58 days |
| 3 | Experimental | Drug: 40 mg ATI 75051 ATI 40mg and 1 placebo tablet, TID, orally, 58 days |
| 4 | Experimental | Drug: 80 mg ATI 75052 ATI 40mg tablets, TID, orally, 58 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 Placebo tablets, TID, orally, 58 days | Drug | 1 |
| 20 mg ATI 75051 ATI 20mg and 1 placebo tablet, TID, orally, 58 days | Drug | 2 |
| 40 mg ATI 75051 ATI 40mg and 1 placebo tablet, TID, orally, 58 days | Drug | 3 |
| 80 mg ATI 75052 ATI 40mg tablets, TID, orally, 58 days | Drug | 4 |
Primary outcome
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
Time frame: Day 42
3 secondary outcomes
Safety and tolerability of ATI 7505
Time frame: 42 days
Time to recurrence of the 2 primary PDS symptoms at day 42
Time frame: 42 days
Effect of ATI 7505 treatment on quality of life indices
Time frame: 42 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
Related trials for Post Prandial Distress Syndrome
Enrolling by invitationObservational study
Small Intestinal Bacterial Overgrowth: A Prospective Registry
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth
Not yet recruiting
Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)
Functional Dyspepsia, Epigastric Pain Syndrome
Not yet recruitingPhase 4
Comparing Acotiamide and Itopride for the Management of Indigestion
Functioanl Dyspepsia, Post Prandial Distress Syndrome
RecruitingPhase 3
A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
Postprandial Distress Syndrome
Recruiting
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Avoidant/Restrictive Food Intake Disorder, Dyspepsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce C Yacyshyn, MD study director
Procter and Gamble
64 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20 mg ATI 7505, 40 mg ATI 7505 and 80 mg ATI 7505 in people with Post Prandial Distress Syndrome, run by Procter and Gamble at 64 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS. (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.