Chronic ConstipationPhase 2NCT00501241
Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
A Phase 2 study testing ATI-7505 in people with Chronic Constipation, run by Procter and Gamble at 23 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- ATI-7505
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jul 2007to 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
- written informed consent
- 18 and 75 years of age
- constipation symptom onset at least 6 months ago \& meet ROME III criteria for chronic constipation
- negative colonoscopy or air contrast barium enema within the past 2 years if ≥50 years of age or within the past 5 years if <50 years of age;
- are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study
Who cannot join
- transabdominal surgery, unstable coronary artery disease, organic gastrointestinal disease, collagen vascular disease, or any alarm symptoms within the 6 months prior to screening;
- taking prohibited medications (including laxatives, herbal remedies)
- participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;
- QTcB >440 msec, abnormal 12-lead ECG, family history of sudden death at age <40 years or history of long QT syndrome
- alcohol or drug abuse within the 6 months prior to screening;
- autonomic dyssynergic defecation
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Research Facility
Anaheim, California
Research Facility
Aventura, Florida
Research Facility
Boston, Massachusetts
Research Facility
Charlottesville, Virginia
Research Facility
Chattanooga, Tennessee
Research Facility
Christiansburg, Virginia
Research Facility
Cincinnati, Ohio
Research Facility
Evansville, Indiana
Research Facility
Great Neck, New York
Research Facility
Hollywood, Florida
Research Facility
Lake Success, New York
Research Facility
Littleton, Colorado
Research Facility
Nashville, Tennessee
Researrch Facility
Newnan, Georgia
Research Facility
Oklahoma City, Oklahoma
Research Facility
Rockford, Illinois
Research Facility
Salt Lake City, Utah
Research facility
San Carlos, California
Research Facility
San Diego, California
Research Facility
South Miami, Florida
Canada3 sites
Research Facility
Montreal, Quebec
Reserach Facility
Québec, Quebec
Research Facility
Saint Charles Borremee, Quebec
About this study
Official title: A Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.
Read the detailed description
This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.
- Conditions
- Chronic Constipation
- Being tested
- ATI-7505
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-7505Drug
Tablet,placebo, BID
ATI-7505Drug
ATI-7505 20 mg BID for 4 weeks
ATI-7505Drug
tablet, 40 mg, BID, $ weeks
ATI-7505Drug
80 mg ATI-7505, BID for 4 weeks
ATI-7505Drug
120 mg ATI-7505, BID, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo twice daily Receives: Drug: ATI-7505 |
| 2 | Experimental | 20 mg ATI-7505, BID for 4 weeks Receives: Drug: ATI-7505 |
| 3 | Experimental | 40 mg ATI, BID, 4 weeks Receives: Drug: ATI-7505 |
| 4 | Experimental | 80 mg ATI-4505, BID for 4 weeks Receives: Drug: ATI-7505 |
| 5 | Experimental | 120 mg ATI-7505, BID for 4 weeks Receives: Drug: ATI-7505 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of spontaneous bowel movements during the first 7 days after randomization
Measured: 7 days
Secondary outcomes (1)
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period
Measured: daily and or weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJul 2007
- 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 Chronic ConstipationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tom G Todaro, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501241
- Sponsor's protocol ID
- 2007003
- Status last verified
- Feb 2008
- First submitted
- 12 Jul 2007
- 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, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT00501241
- Acronym / sponsor ID
- 2007003
- Conditions
- Chronic Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Jul 2007 (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.
The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.
Detailed description
This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: ATI-7505placebo twice daily |
| 2 | Experimental | Drug: ATI-750520 mg ATI-7505, BID for 4 weeks |
| 3 | Experimental | Drug: ATI-750540 mg ATI, BID, 4 weeks |
| 4 | Experimental | Drug: ATI-750580 mg ATI-4505, BID for 4 weeks |
| 5 | Experimental | Drug: ATI-7505120 mg ATI-7505, BID for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- written informed consent
- 18 and 75 years of age
- constipation symptom onset at least 6 months ago \& meet ROME III criteria for chronic constipation
- negative colonoscopy or air contrast barium enema within the past 2 years if ≥50 years of age or within the past 5 years if <50 years of age;
- are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study
Key exclusion criteria (6 listed)
- transabdominal surgery, unstable coronary artery disease, organic gastrointestinal disease, collagen vascular disease, or any alarm symptoms within the 6 months prior to screening;
- taking prohibited medications (including laxatives, herbal remedies)
- participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;
- QTcB >440 msec, abnormal 12-lead ECG, family history of sudden death at age <40 years or history of long QT syndrome
- alcohol or drug abuse within the 6 months prior to screening;
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 |
|---|---|---|
| ATI-7505Tablet,placebo, BID | Drug | 1 |
| ATI-7505ATI-7505 20 mg BID for 4 weeks | Drug | 2 |
| ATI-7505tablet, 40 mg, BID, $ weeks | Drug | 3 |
| ATI-750580 mg ATI-7505, BID for 4 weeks | Drug | 4 |
| ATI-7505120 mg ATI-7505, BID, for 4 weeks | Drug | 5 |
Primary outcome
Total number of spontaneous bowel movements during the first 7 days after randomization
Time frame: 7 days
1 secondary outcome
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period
Time frame: daily and or weekly
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.
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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.
Tom G Todaro, MD study director
Procter and Gamble
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-7505 in people with Chronic Constipation, run by Procter and Gamble at 23 sites in 2 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 5 inclusion and 6 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 23 sites in United States, Canada. 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?
Total number of spontaneous bowel movements during the first 7 days after randomization (time frame: 7 days). 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; AzTrials last refreshed its copy on 6 Nov 2026.