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The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A3309 low dose | Experimental | Administered once daily for the duration of the study |
|
| A3309 intermediate dose | Experimental | Administered once daily for the duration of the study. |
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| A3309 high dose | Experimental | Administered once daily for the duration of the study |
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| Placebo | Placebo Comparator | Administered once daily for the duration of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A3309 | Drug | A3309 in three different dosage levels or placebo once daily for the duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Frequency of Spontaneous Bowel Movements | Primary ep W 1 | Baseline, weekly, up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs) | A CSBM responder is defined as per FDA draft guidance for IBS-C: An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment | Baseline, weekly and up to 8 weeks |
| Time to First Bowel Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Graffner, MD | Albireo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albireo Investigative Site | Huntsville | Alabama | 35801 | United States | ||
| Albireo Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21606974 | Result | Chey WD, Camilleri M, Chang L, Rikner L, Graffner H. A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation. Am J Gastroenterol. 2011 Oct;106(10):1803-12. doi: 10.1038/ajg.2011.162. Epub 2011 May 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elobixibat (A3309) 5 mg | Administered once daily for the duration of the study |
| FG001 | Elobixibat (A3309) 10 mg | Administered once daily for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| First week |
| Stool Consistency Change From Baseline | Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state. | Baseline, weekly and up to 8 weeks |
| LDL/HDL Ratio | Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted | Baseline and 8 weeks of treatment |
| Straining Change From Baseline | Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining. | Baseline and during 8 weeks of treatment |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Albireo Investigative Site | Phoenix | Arizona | 85020 | United States |
| Albireo Investigative Site | Anaheim | California | 92801 | United States |
| Albireo Investigative Site | Encinitas | California | 92024 | United States |
| Albireo Investigative Site | San Diego | California | 92108 | United States |
| Albireo Investigative Site | Colorado Springs | Colorado | 80904 | United States |
| Albireo Investigative Site | Boynton Beach | Florida | 33426 | United States |
| Albireo Investigative Site | Inverness | Florida | 34452 | United States |
| Albireo Investigative Site | Peoria | Illinois | 61602 | United States |
| Albireo Investigative Site | Clive | Iowa | 50325 | United States |
| Albireo Investigative Site | Davenport | Iowa | 52807 | United States |
| Albireo Investigative Site | Mission | Kansas | 66202 | United States |
| Albireo Investigative Site | Overland Park | Kansas | 66215 | United States |
| Albireo Investigative Site | Monroe | Louisiana | 71201 | United States |
| Albireo Investigative Site | Shreveport | Louisiana | 71103 | United States |
| Albireo Investigative Site | Annapolis | Maryland | 21401 | United States |
| Albireo Investigative Site | Baltimore | Maryland | 21215 | United States |
| Albireo Investigative Site | Hollywood | Maryland | 20636 | United States |
| Albireo Investigative Site | Chesterfield | Michigan | 48047 | United States |
| Albireo Investigative Site | Henderson | Nevada | 89104 | United States |
| Albireo Investigative Site | Marlton | New Jersey | 08053 | United States |
| Albireo Investigative Site | Albuquerque | New Mexico | 87108 | United States |
| Albireo Investigative Site | Great Neck | New York | 11021 | United States |
| Albireo Investigative Site | Charlotte | North Carolina | 28211 | United States |
| Albireo Investigative Site | Greensboro | North Carolina | 27408 | United States |
| Albireo Investigative Site | Harrisburg | North Carolina | 28075 | United States |
| Albireo Investigative Site | Statesville | North Carolina | 28625 | United States |
| Albireo Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Albireo Investigative Site | Cincinnati | Ohio | 45224 | United States |
| Albireo Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Albireo Investigative Site | Dayton | Ohio | 45440 | United States |
| Albireo Investigative Site | Oklahoma City | Oklahoma | 73116 | United States |
| Albireo Investigative Site | Levittown | Pennsylvania | 19056 | United States |
| Albireo Investigative Site | Anderson | South Carolina | 29621 | United States |
| Albireo Investigative Site | Chattanooga | Tennessee | 37411 | United States |
| Albireo Investigative Site | Kingsport | Tennessee | 37660 | United States |
| Albireo Investigative Site | El Paso | Texas | 79905 | United States |
| Albireo Investigative Site | Longview | Texas | 75605 | United States |
| Albireo Investigative Site | San Antonio | Texas | 78229 | United States |
| Albireo Investigative Site | Ogden | Utah | 84405 | United States |
| Albireo Investigative Site | Salt Lake City | Utah | 84107 | United States |
| Albireo Investigative Site | Lynchburg | Virginia | 24502 | United States |
| Albireo Investigative Site | La Crosse | Wisconsin | 54601 | United States |
| FG002 | Elobixibat (A3309) 15 mg | Administered once daily for the duration of the study |
| FG003 | Placebo | Administered once daily for the duration of the study |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Elobixibat (A3309) 5 mg | Administered once daily for the duration of the study |
| BG001 | Elobixibat (A3309) 10 mg | Administered once daily for the duration of the study. |
| BG002 | Elobixibat (A3309) 15 mg | Administered once daily for the duration of the study |
| BG003 | Placebo | Administered once daily for the duration of the study |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Frequency of Spontaneous Bowel Movements | Primary ep W 1 | ITT population | Posted | Least Squares Mean | Standard Error | Number of SBMs | Baseline, weekly, up to 8 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs) | 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 | ITT population | Posted | Number | participants | Baseline, weekly and up to 8 weeks |
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| Secondary | Time to First Bowel Movement | ITT population | Posted | Median | 95% Confidence Interval | hours | First week |
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| Secondary | Stool Consistency Change From Baseline | Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state. | ITT population | Posted | Least Squares Mean | Standard Deviation | units on a scale (1-7) | Baseline, weekly and up to 8 weeks |
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| Secondary | LDL/HDL Ratio | Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted | ITT population | Posted | Least Squares Mean | Standard Error | Ratio | Baseline and 8 weeks of treatment |
|
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| Secondary | Straining Change From Baseline | Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining. | ITT population | Posted | Least Squares Mean | Standard Error | units on a scale (1-5) | Baseline and during 8 weeks of treatment |
|
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From randomization to end of follow-up 14 days after end of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elobixibat (A3309) 5 mg | Administered once daily for the duration of the study | 1 | 48 | 5 | 48 | ||
| EG001 | Elobixibat (A3309) 10 mg | Administered once daily for the duration of the study. | 1 | 47 | 5 | 47 | ||
| EG002 | Elobixibat (A3309) 15 mg | Administered once daily for the duration of the study | 0 | 48 | 13 | 48 | ||
| EG003 | Placebo | Administered once daily for the duration of the study | 1 | 47 | 3 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment | Cancer diagnosed 5 days after treatment start Not considered related to study drug |
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| Bleeding colonic diverticulum | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment | Colonoscopy verified bleeding diverticulum 14 days after end of treatment. Not considered related to study drug |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment | Not considered related to study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mats Ekelund | Albireo | +46 31 741 14 80 | info@albireopharma.com |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C581303 | elobixibat |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| 2-Sided |
| 0 |
| Superiority or Other |
| ANCOVA | <0.001 | 2-Sided | 0 | Superiority or Other |
| Counts |
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