Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation (ACCESS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01007123 |
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Recruitment Status :
Completed
First Posted : November 3, 2009
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
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Sponsor:
Albireo
Information provided by (Responsible Party):
Albireo
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Constipation Chronic Constipation | Drug: A3309 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 190 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Constipation
| Arm | Intervention/treatment |
|---|---|
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Experimental: A3309 low dose
Administered once daily for the duration of the study
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Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study |
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Experimental: A3309 intermediate dose
Administered once daily for the duration of the study.
|
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study |
|
Experimental: A3309 high dose
Administered once daily for the duration of the study
|
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study |
|
Placebo Comparator: Placebo
Administered once daily for the duration of the study
|
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study |
Primary Outcome Measures :
- Change From Baseline in Frequency of Spontaneous Bowel Movements [ Time Frame: Baseline, weekly, up to 8 weeks ]Primary ep W 1
Secondary Outcome Measures :
- Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs) [ Time Frame: Baseline, weekly and up to 8 weeks ]
A CSBM responder is defined as per FDA draft guidance for IBS-C:
An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
- Time to First Bowel Movement [ Time Frame: First week ]
- Stool Consistency Change From Baseline [ Time Frame: Baseline, weekly and up to 8 weeks ]Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
- LDL/HDL Ratio [ Time Frame: Baseline and 8 weeks of treatment ]Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
- Straining Change From Baseline [ Time Frame: Baseline and during 8 weeks of treatment ]Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient meets protocol specified criteria for constipation
- Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable
Exclusion Criteria:
- Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
- Patient reports loose stools
- Patient has IBS with pain/discomfort as predominant symptom
- Patient needs medications prohibited as specified in the protocol
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007123
Locations
| United States, Alabama | |
| Albireo Investigative Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Albireo Investigative Site | |
| Chandler, Arizona, United States, 85224 | |
| Albireo Investigative Site | |
| Phoenix, Arizona, United States, 85020 | |
| United States, California | |
| Albireo Investigative Site | |
| Anaheim, California, United States, 92801 | |
| Albireo Investigative Site | |
| Encinitas, California, United States, 92024 | |
| Albireo Investigative Site | |
| San Diego, California, United States, 92108 | |
| United States, Colorado | |
| Albireo Investigative Site | |
| Colorado Springs, Colorado, United States, 80904 | |
| United States, Florida | |
| Albireo Investigative Site | |
| Boynton Beach, Florida, United States, 33426 | |
| Albireo Investigative Site | |
| Inverness, Florida, United States, 34452 | |
| United States, Illinois | |
| Albireo Investigative Site | |
| Peoria, Illinois, United States, 61602 | |
| United States, Iowa | |
| Albireo Investigative Site | |
| Clive, Iowa, United States, 50325 | |
| Albireo Investigative Site | |
| Davenport, Iowa, United States, 52807 | |
| United States, Kansas | |
| Albireo Investigative Site | |
| Mission, Kansas, United States, 66202 | |
| Albireo Investigative Site | |
| Overland Park, Kansas, United States, 66215 | |
| United States, Louisiana | |
| Albireo Investigative Site | |
| Monroe, Louisiana, United States, 71201 | |
| Albireo Investigative Site | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| Albireo Investigative Site | |
| Annapolis, Maryland, United States, 21401 | |
| Albireo Investigative Site | |
| Baltimore, Maryland, United States, 21215 | |
| Albireo Investigative Site | |
| Hollywood, Maryland, United States, 20636 | |
| United States, Michigan | |
| Albireo Investigative Site | |
| Chesterfield, Michigan, United States, 48047 | |
| United States, Nevada | |
| Albireo Investigative Site | |
| Henderson, Nevada, United States, 89104 | |
| United States, New Jersey | |
| Albireo Investigative Site | |
| Marlton, New Jersey, United States, 08053 | |
| United States, New Mexico | |
| Albireo Investigative Site | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Albireo Investigative Site | |
| Great Neck, New York, United States, 11021 | |
| United States, North Carolina | |
| Albireo Investigative Site | |
| Charlotte, North Carolina, United States, 28211 | |
| Albireo Investigative Site | |
| Greensboro, North Carolina, United States, 27408 | |
| Albireo Investigative Site | |
| Harrisburg, North Carolina, United States, 28075 | |
| Albireo Investigative Site | |
| Statesville, North Carolina, United States, 28625 | |
| Albireo Investigative Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Albireo Investigative Site | |
| Cincinnati, Ohio, United States, 45224 | |
| Albireo Investigative Site | |
| Cincinnati, Ohio, United States, 45242 | |
| Albireo Investigative Site | |
| Dayton, Ohio, United States, 45440 | |
| United States, Oklahoma | |
| Albireo Investigative Site | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Pennsylvania | |
| Albireo Investigative Site | |
| Levittown, Pennsylvania, United States, 19056 | |
| United States, South Carolina | |
| Albireo Investigative Site | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Tennessee | |
| Albireo Investigative Site | |
| Chattanooga, Tennessee, United States, 37411 | |
| Albireo Investigative Site | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Albireo Investigative Site | |
| El Paso, Texas, United States, 79905 | |
| Albireo Investigative Site | |
| Longview, Texas, United States, 75605 | |
| Albireo Investigative Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Albireo Investigative Site | |
| Ogden, Utah, United States, 84405 | |
| Albireo Investigative Site | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Albireo Investigative Site | |
| Lynchburg, Virginia, United States, 24502 | |
| United States, Wisconsin | |
| Albireo Investigative Site | |
| La Crosse, Wisconsin, United States, 54601 | |
Sponsors and Collaborators
Albireo
Investigators
| Study Chair: | Hans Graffner, MD | Albireo |
Publications of Results:
| Responsible Party: | Albireo |
| ClinicalTrials.gov Identifier: | NCT01007123 |
| Other Study ID Numbers: |
A3309-002 |
| First Posted: | November 3, 2009 Key Record Dates |
| Results First Posted: | March 22, 2017 |
| Last Update Posted: | March 22, 2017 |
| Last Verified: | February 2017 |
Keywords provided by Albireo:
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Chronic idiopathic constipation A3309 |
Additional relevant MeSH terms:
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Constipation Signs and Symptoms, Digestive |