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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001600-38 | EudraCT Number |
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The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eluxadoline 75 mg | Experimental | Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. |
|
| Eluxadoline 100 mg | Experimental | Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. |
|
| Placebo | Placebo Comparator | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eluxadoline | Drug | Oral tablets twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces. | Up to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces. |
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Inclusion Criteria:
Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
Participant has had a colonoscopy performed:
Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
Since the onset (if applicable) of any of the following alarm features for participants of any age:
Female participants must be:
Exclusion Criteria:
Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
Participant has a history of diverticulitis within 3 months prior to Prescreening.
Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
Participant has any of the following surgical history:
Other protocol-specific eligibility criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Furiex Research Site | Athens | Alabama | 35611 | United States | ||
| Furiex Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28167156 | Derived | Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3. | |
| 26789872 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eluxadoline 75 mg | Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. |
| FG001 | Eluxadoline 100 mg | Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Oral tablets twice daily |
|
| Up to 26 Weeks |
| Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals | Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder. | 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24) |
| Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals | Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder. | 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24) |
| Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals | IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder. | 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24) |
| Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale | IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation. | Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT]) |
| Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale | Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder. | 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26) |
| Change From Baseline in Daily Abdominal Discomfort Scores | Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased. | Baseline, Weeks 4, 12 and 26 |
| Change From Baseline in Daily Abdominal Bloating Scores | Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased. | Baseline, Weeks 4, 12 and 26 |
| Number of Bowel Movements Per Day | Participants recorded the number of bowel movements over 24 hours daily throughout the treatment. | Weeks 4, 12 and 26 |
| Number of Bowel Incontinence Episodes | Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment. | Weeks 4, 12 and 26 |
| Number of Bowel Incontinence Free Days | An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days. | Weeks 4, 12 and 26 |
| Number of Urgency Episodes Per Day | Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment. | Weeks 4, 12 and 26 |
| IBS-QoL Total Scores | The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. | Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT) |
| Change From Baseline in IBS-QoL Total Scores | The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved. | Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT |
| Birmingham |
| Alabama |
| 35213 |
| United States |
| Furiex Research Site | Foley | Alabama | 36535 | United States |
| Furiex Research Site | Huntsville | Alabama | 35802 | United States |
| Furiex Research Site | Ozark | Alabama | 36360 | United States |
| Furiex Research Site | Chandler | Arizona | 85224 | United States |
| Furiex Research Site | Glendale | Arizona | 85306 | United States |
| Furiex Research Site | Mesa | Arizona | 85213 | United States |
| Furiex Research Site | Phoenix | Arizona | 85018 | United States |
| Furiex Research Site | Tucson | Arizona | 85712 | United States |
| Furiex Research Site | Little Rock | Arkansas | 72211 | United States |
| Furiex Research Site | Little Rock | Arkansas | 72212 | United States |
| Furiex Research Site | North Little Rock | Arkansas | 72117 | United States |
| Furiex Research Site | Azusa | California | 91702 | United States |
| Furiex Research Site | Bell Gardens | California | 90201 | United States |
| Furiex Research Site | Beverly Hills | California | 90211 | United States |
| Furiex Research Site | Carson | California | 91105 | United States |
| Furiex Research Site | Chula Vista | California | 91910 | United States |
| Furiex Research Site | Corona | California | 92880 | United States |
| Furiex Research Site | El Cajon | California | 92020 | United States |
| Furiex Research Site | Encino | California | 91436 | United States |
| Furiex Research Site | Garden Grove | California | 92843 | United States |
| Furiex Research Site | Lomita | California | 90717 | United States |
| Furiex Research Site | Los Angeles | California | 90022 | United States |
| Furiex Research Site | Monterey Park | California | 91754 | United States |
| Furiex Research Site | Murrieta | California | 92562 | United States |
| Furiex Research Site | Newport Beach | California | 92663 | United States |
| Furiex Research Site | North Hollywood | California | 91606 | United States |
| Furiex Research Site | Oakland | California | 94612 | United States |
| Furiex Research Site | Oxnard | California | 93030 | United States |
| Furiex Research Site | Pismo Beach | California | 93449 | United States |
| Furiex Research Site | Poway | California | 92064 | United States |
| Furiex Research Site | Riverside | California | 92501 | United States |
| Furiex Research Site | Roseville | California | 95661 | United States |
| Furiex Research Site | Sacramento | California | 95825 | United States |
| Furiex Research Site | San Diego | California | 92103 | United States |
| Furiex Research Site | San Diego | California | 92114 | United States |
| Furiex Research Site | Santa Monica | California | 90404 | United States |
| Furiex Research Site | Thousand Oaks | California | 91360 | United States |
| Furiex Research Site | Colorado Springs | Colorado | 80904 | United States |
| Furiex Research Site | Colorado Springs | Colorado | 80907 | United States |
| Furiex Research Site | Lafayette | Colorado | 80026 | United States |
| Furiex Research Site | Lakewood | Colorado | 80215 | United States |
| Furiex Research Site | Longmont | Colorado | 80501 | United States |
| Furiex Research Site | Norwalk | Connecticut | 06851 | United States |
| Furiex Research Site | Ridgefield | Connecticut | 06877 | United States |
| Furiex Research Site | Boca Raton | Florida | 33428 | United States |
| Furiex Research Site | Brandon | Florida | 33511 | United States |
| Furiex Research Site | Clearwater | Florida | 33765 | United States |
| Furiex Research Site | Cooper City | Florida | 33024 | United States |
| Furiex Research Site | Coral Springs | Florida | 33065 | United States |
| Furiex Research Site | Crystal River | Florida | 34429 | United States |
| Furiex Research Site | Doral | Florida | 33172 | United States |
| Furiex Research Site | Eustis | Florida | 32726 | United States |
| Furix Research Site | Hialeah | Florida | 33013 | United States |
| Furiex Research Site | Hialeah | Florida | 33016 | United States |
| Furiex Research Site | Inverness | Florida | 34452 | United States |
| Furiex Research Site | Jacksonville | Florida | 32216 | United States |
| Furiex Research Site | Kissimmee | Florida | 34741 | United States |
| Furiex Research Site | Maitland | Florida | 32751 | United States |
| Furiex Research Site | Melbourne | Florida | 32935 | United States |
| Furiex Research Site | Miami | Florida | 33015 | United States |
| Furiex Research Site | Miami | Florida | 33125 | United States |
| Furiex Research Site | Miami | Florida | 33126 | United States |
| Furiex Research Site | Miami | Florida | 33133 | United States |
| Furiex Research Site | Miami | Florida | 33135 | United States |
| Furiex Research Site | Miami | Florida | 33144 | United States |
| Furiex Research Site | Miami | Florida | 33155 | United States |
| Furiex Research Site | Miami | Florida | 33175 | United States |
| Furiex Research Site | Miami Springs | Florida | 33166 | United States |
| Furiex Research Site | Miramar | Florida | 33025 | United States |
| Furiex Research Site | Naples | Florida | 34102 | United States |
| Furiex Research Site | New Port Richey | Florida | 34653 | United States |
| Furiex Research Site | New Smyrna Beach | Florida | 32168 | United States |
| Furiex Research Site | Orlando | Florida | 32801 | United States |
| Furiex Research Site | Orlando | Florida | 32806 | United States |
| Furiex Research Site | Orlando | Florida | 32819 | United States |
| Furiex Research Site | Ormond Beach | Florida | 32174 | United States |
| Furiex Research Site | Oviedo | Florida | 32765 | United States |
| Furiex Research Site | Palm Beach | Florida | 33472 | United States |
| Furiex Research Site | Pinellas Park | Florida | 33781 | United States |
| Furiex Research Site | Pinellas Park | Florida | 33782 | United States |
| Furiex Research Site | Port Orange | Florida | 32129 | United States |
| Furiex Research Site | Sanford | Florida | 32771 | United States |
| Furiex Research Site | Sebastian | Florida | 32958 | United States |
| Furiex Research Site | South Miami | Florida | 33143 | United States |
| Furiex Research Site | Tampa | Florida | 33606 | United States |
| Furiex Research Site | Tampa | Florida | 33607 | United States |
| Furiex Research Site | Venice | Florida | 34292 | United States |
| Furiex Research Site | Wellington | Florida | 33414 | United States |
| Furiex Research Site | Winter Haven | Florida | 33880 | United States |
| Furiex Research Site | Winter Park | Florida | 32792 | United States |
| Furiex Research Site | Atlanta | Georgia | 30338 | United States |
| Furiex Research Site | Blue Ridge | Georgia | 30513 | United States |
| Furiex Research Site | Johns Creek | Georgia | 30097 | United States |
| Furiex Research Site | Lilburn | Georgia | 30047 | United States |
| Furiex Research Site | Oakwood | Georgia | 30566 | United States |
| Furiex Research Site | Perry | Georgia | 31069 | United States |
| Furiex Research Site | Snellville | Georgia | 30078 | United States |
| Furiex Research Site | Eagle | Idaho | 83616 | United States |
| Furiex Research Site | Addison | Illinois | 60101 | United States |
| Furiex Research Site | Chicago | Illinois | 60611 | United States |
| Furiex Research Site | Morton | Illinois | 61550 | United States |
| Furiex Research Site | Brownsburg | Indiana | 46112 | United States |
| Furiex Research Site | Evansville | Indiana | 47714 | United States |
| Furiex Research Site | Indianapolis | Indiana | 46202 | United States |
| Furiex Research Site | Clive | Iowa | 50325 | United States |
| Furiex Research Site | Davenport | Iowa | 52807 | United States |
| Furiex Research Site | Iowa City | Iowa | 52242 | United States |
| Furiex Research Site | West Des Moines | Iowa | 50266 | United States |
| Furiex Research Site | Newton | Kansas | 67114 | United States |
| Furiex Research Site | Prairie Village | Kansas | 66206 | United States |
| Furiex Research Site | Shawnee Mission | Kansas | 66218 | United States |
| Furiex Research Site | Wichita | Kansas | 67203 | United States |
| Furiex Research Site | Wichita | Kansas | 67205 | United States |
| Furiex Research Site | Crestview Hills | Kentucky | 41017 | United States |
| Furiex Research Site | Hawesville | Kentucky | 42348 | United States |
| Furiex Research Site | Lexington | Kentucky | 40509 | United States |
| Furiex Research Site | Lexington | Kentucky | 40536 | United States |
| Furiex Research Site | Louisville | Kentucky | 40202 | United States |
| Furiex Research Site | Madisonville | Kentucky | 42431 | United States |
| Furiex Research Site | Owensboro | Kentucky | 42303 | United States |
| Furiex Research Site | Baker | Louisiana | 70794 | United States |
| Furiex Research Site | Covington | Louisiana | 70435 | United States |
| Furiex Research Site | Hammond | Louisiana | 70403 | United States |
| Furiex Research Site | Metairie | Louisiana | 70006 | United States |
| Furiex Research Site | New Orleans | Louisiana | 70124 | United States |
| Furiex Research Site | Opelousas | Louisiana | 70570 | United States |
| Furiex Research Site | Shreveport | Louisiana | 71101 | United States |
| Furiex Research Site | Shreveport | Louisiana | 71105 | United States |
| Furiex Research Site | Bangor | Maine | 04401 | United States |
| Furiex Research Site | Annapolis | Maryland | 21401 | United States |
| Furiex Research Site | Chevy Chase | Maryland | 20815 | United States |
| Furiex Research Site | Brockton | Massachusetts | 02301 | United States |
| Furiex Research Site | Watertown | Massachusetts | 02472 | United States |
| Furiex Research Site | Ann Arbor | Michigan | 48106 | United States |
| Furiex Research Site | Southfield | Michigan | 48034 | United States |
| Furiex Research Site | Stevensville | Michigan | 49127 | United States |
| Furiex Research Site | Chaska | Minnesota | 55318 | United States |
| Furiex Research Site | Jackson | Mississippi | 39202 | United States |
| Furiex Research Site | City of Saint Peters | Missouri | 63376 | United States |
| Furiex Research Site | Jefferson City | Missouri | 65109 | United States |
| Furiex Research Site | St Louis | Missouri | 63128 | United States |
| Furiex Research Site | St Louis | Missouri | 63141 | United States |
| Furiex Research Site | Billings | Montana | 59102 | United States |
| Furiex Research Site | Bellevue | Nebraska | 68005 | United States |
| Furiex Research Site | Omaha | Nebraska | 68114 | United States |
| Furiex Research Site | Omaha | Nebraska | 68134 | United States |
| Furiex Research Site | Las Vegas | Nevada | 89106 | United States |
| Furiex Research Site | Las Vegas | Nevada | 89119 | United States |
| Furiex Research Site | Collingswood | New Jersey | 08108 | United States |
| Furiex Research Site | Edison | New Jersey | 08817 | United States |
| Furiex Research Site | Albuquerque | New Mexico | 87106 | United States |
| Furiex Research Site | Brooklyn | New York | 11230 | United States |
| Furiex Research Site | Endwell | New York | 13760 | United States |
| Furiex Research Site | Great Neck | New York | 11023 | United States |
| Furiex Research Site | Hartsdale | New York | 10530 | United States |
| Furiex Research Site | Kew Gardens | New York | 11415 | United States |
| Furiex Research Site | New Windsor | New York | 12553 | United States |
| Furiex Research Site | New York | New York | 10016 | United States |
| Furiex Research Site | North Massapequa | New York | 11758 | United States |
| Furiex Research Site | Poughkeepsie | New York | 12601 | United States |
| Furiex Research Site | Asheville | North Carolina | 28801 | United States |
| Furiex Research Site | Asheville | North Carolina | 28803 | United States |
| Furiex Research Site | Charlotte | North Carolina | 28211 | United States |
| Furiex Research Site | Durham | North Carolina | 27713 | United States |
| Furiex Research Site | Fayetteville | North Carolina | 28304 | United States |
| Furiex Research Site | Greensboro | North Carolina | 27403 | United States |
| Furiex Research Site | Hickory | North Carolina | 28602 | United States |
| Furiex Research Site | High Point | North Carolina | 27262 | United States |
| Furiex Research Site | Kinston | North Carolina | 28501 | United States |
| Furiex Research Site | Lenoir | North Carolina | 28645 | United States |
| Furiex Research Site | Raleigh | North Carolina | 27609 | United States |
| Furiex Research Site | Raleigh | North Carolina | 27612 | United States |
| Furiex Research Site | Salisbury | North Carolina | 28144 | United States |
| Furiex Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Furiex Research Site | Fargo | North Dakota | 58103 | United States |
| Furiex Research Site | Fargo | North Dakota | 58104 | United States |
| Furiex Research Site | Beavercreek | Ohio | 45432 | United States |
| Furiex Research Site | Berea | Ohio | 44017 | United States |
| Furiex Research Site | Centerville | Ohio | 45459 | United States |
| Furiex Research Site | Cincinnati | Ohio | 45212 | United States |
| Furiex Research Site | Cincinnati | Ohio | 45219 | United States |
| Furiex Research Site | Columbus | Ohio | 43215 | United States |
| Furiex Research Site | Dayton | Ohio | 45415 | United States |
| Furiex Research Site | Dayton | Ohio | 45419 | United States |
| Furiex Research Site | Englewood | Ohio | 45322 | United States |
| Furiex Research Site | Franklin | Ohio | 45005 | United States |
| Furiex Research Site | Marion | Ohio | 43302 | United States |
| Furiex Research Site | Miamisburg | Ohio | 45342 | United States |
| Furiex Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Furiex Research Site | Wadsworth | Ohio | 44281 | United States |
| Furiex Research Site | Zanesville | Ohio | 43701 | United States |
| Furiex Research Site | Tulsa | Oklahoma | 74104 | United States |
| Furiex Research Site | Tulsa | Oklahoma | 74135 | United States |
| Furiex Research Site | Tulsa | Oklahoma | 74136 | United States |
| Furiex Research Site | Belle Vernon | Pennsylvania | 15012 | United States |
| Furiex Research Site | Jenkintown | Pennsylvania | 19046 | United States |
| Furiex Research Site | Johnstown | Pennsylvania | 15905 | United States |
| Furiex Research Site | Lansdale | Pennsylvania | 19446 | United States |
| Furiex Research Site | Philadelphia | Pennsylvania | 19142 | United States |
| Furiex Research Site | Philadelphia | Pennsylvania | 19152 | United States |
| Furiex Research Site | Pittsburgh | Pennsylvania | 15236 | United States |
| Furiex Research Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Furiex Research Site | Uniontown | Pennsylvania | 15401 | United States |
| Furiex Research Site | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Furiex Research Site | Cumberland | Rhode Island | 02864 | United States |
| Furiex Research Site | East Providence | Rhode Island | 02914 | United States |
| Furiex Research Site | Anderson | South Carolina | 29621 | United States |
| Furiex Research Site | Charleston | South Carolina | 29406 | United States |
| Furiex Research Site | Fort Mill | South Carolina | 29707 | United States |
| Furiex Research Site | Greenville | South Carolina | 29615 | United States |
| Furiex Research Site | Greer | South Carolina | 29650 | United States |
| Furiex Research Site | Greer | South Carolina | 29651 | United States |
| Furiex Research Site | Myrtle Beach | South Carolina | 29588 | United States |
| Furiex Research Site | Myrtle Beach | South Carolina | 29752 | United States |
| Furiex Research Site | Simpsonville | South Carolina | 29681 | United States |
| Furiex Research Site | Summerville | South Carolina | 29485 | United States |
| Furiex Research Site | Bristol | Tennessee | 37620 | United States |
| Furiex Research Site | Chattanooga | Tennessee | 37421 | United States |
| Furiex Research Site | Clarksville | Tennessee | 37043 | United States |
| Furiex Research Site | Columbia | Tennessee | 38401 | United States |
| Furiex Research Site | Franklin | Tennessee | 37064 | United States |
| Furiex Research Site | Johnson City | Tennessee | 37604 | United States |
| Furiex Research Site | Memphis | Tennessee | 38119 | United States |
| Furiex Research Site | Smyrna | Tennessee | 37167 | United States |
| Furiex Research Site | Austin | Texas | 78745 | United States |
| Furiex Research Site | Austin | Texas | 78756 | United States |
| Furiex Research Site | Baytown | Texas | 77521 | United States |
| Furiex Research Site | Beaumont | Texas | 77701 | United States |
| Furiex Research Site | Dallas | Texas | 75224 | United States |
| Furiex Research Site | El Paso | Texas | 79905 | United States |
| Furiex Research Site | Houston | Texas | 77074 | United States |
| Furiex Research Site | Houston | Texas | 77079 | United States |
| Furiex Research Site | Houston | Texas | 77089 | United States |
| Furiex Research Site | Houston | Texas | 77098 | United States |
| Furiex Research Site | Marshall | Texas | 75670 | United States |
| Furiex Research Site | Plano | Texas | 75024 | United States |
| Furiex Research Site | San Antonio | Texas | 78209 | United States |
| Furiex Research Site | San Antonio | Texas | 78229 | United States |
| Furiex Research Site | San Antonio | Texas | 78258 | United States |
| Furiex Research Site | Sugar Land | Texas | 77478 | United States |
| Furiex Research Site | Clinton | Utah | 84015 | United States |
| Furiex Research Site | Draper | Utah | 84020 | United States |
| Furiex Research Site | Logan | Utah | 84341 | United States |
| Furiex Research Site | Ogden | Utah | 84405 | United States |
| Furiex Research Site | Salt Lake City | Utah | 84102 | United States |
| Furiex Research Site | West Jordan | Utah | 84088 | United States |
| Furiex Research Site | Lynchburg | Virginia | 24502 | United States |
| Furiex Research Site | Richmond | Virginia | 23219 | United States |
| Furiex Research Site | Williamsburg | Virginia | 23185 | United States |
| Furiex Research Site | Spokane | Washington | 99202 | United States |
| Furiex Research Site | Spokane | Washington | 99204 | United States |
| Furiex Research Site | Spokane | Washington | 99208 | United States |
| Furiex Research Site | Wenatchee | Washington | 98801 | United States |
| Furiex Research Site | Morgantown | West Virginia | 26505 | United States |
| Furiex Research Site | Wauwatosa | Wisconsin | 53226 | United States |
| Furiex Research Site | Kamloops | British Columbia | V2C 1K7 | Canada |
| Furiex Research Site | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Furiex Research Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Furiex Research Site | Bridgewater | Nova Scotia | B4V 3N2 | Canada |
| Furiex Research Site | Halifax | Nova Scotia | B3K 2M5 | Canada |
| Furiex Research Site | Cambridge | Ontario | N1S 2M6 | Canada |
| Furiex Research Site | London | Ontario | N6A 5R8 | Canada |
| Furiex Research Site | Niagara Falls | Ontario | L2G 1J4 | Canada |
| Furiex Research Site | Oshawa | Ontario | L1H 1B9 | Canada |
| Furiex Research Site | Chesterfield | Derbyshire | S40 4AA | United Kingdom |
| Furiex Research Site | Blackpool | Lancashire | FY3 7EN | United Kingdom |
| Furiex Research Site | Thornton-Cleveleys | Lancashire | FY5 3LF | United Kingdom |
| Furiex Research Site | Burbage | Leicestershire | LE10 2SE | United Kingdom |
| Furiex Research Site | Royal Leamington Spa | Warwickshire | CV32 4RA | United Kingdom |
| Furiex Research Site | Chippenham | Wiltshire | SN14 6GT | United Kingdom |
| Furiex Research Site | Bath | BA2 3HT | United Kingdom |
| Furiex Research Site | Bath | BA2 4BY | United Kingdom |
| Furiex Research Site | Coventry | CV6 4DD | United Kingdom |
| Furiex Research Site | Dorking | RH4 1SD | United Kingdom |
| Furiex Research Site | Haxey | DN9 2HY | United Kingdom |
| Furiex Research Site | London | E11 1NR | United Kingdom |
| Furiex Research Site | Shrewsbury | SY3 8XQ | United Kingdom |
| Furiex Research Site | Southampton | SO16 6YD | United Kingdom |
| Furiex Research Site | Strensall | YO32 5UA | United Kingdom |
| Furiex Research Site | Thornton | FY5 2TZ | United Kingdom |
| Furiex Research Site | Torpoint | PL11 2JW | United Kingdom |
| Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180. |
| FG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. |
| Attended Week 12 Visit |
|
| Attended Week 26 Visit |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled Set included 1282 participants who were randomized or received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eluxadoline 75 mg | Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. |
| BG001 | Eluxadoline 100 mg | Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. |
| BG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Body Mass Index (BMI) | The number analyzed indicates number of participants analyzed for this baseline characteristics. | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | Up to 12 Weeks |
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| Secondary | Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces. | ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | Up to 26 Weeks |
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| Secondary | Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals | Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder. | ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals | Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder. | ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals | IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder. | ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale | IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation. | ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale | Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder. | ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. | Posted | Number | percentage of participants | 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Abdominal Discomfort Scores | Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 12 and 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Abdominal Bloating Scores | Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 12 and 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Bowel Movements Per Day | Participants recorded the number of bowel movements over 24 hours daily throughout the treatment. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | bowel movements per day | Weeks 4, 12 and 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Bowel Incontinence Episodes | Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | incontinence episodes | Weeks 4, 12 and 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Bowel Incontinence Free Days | An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | days | Weeks 4, 12 and 26 |
|
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| Secondary | Number of Urgency Episodes Per Day | Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | episodes per day | Weeks 4, 12 and 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | IBS-QoL Total Scores | The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in IBS-QoL Total Scores | The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved. | Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT |
|
Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eluxadoline 75 mg | Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. | 0 | 428 | 25 | 428 | 84 | 428 |
| EG001 | Eluxadoline 100 mg | Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. | 0 | 479 | 27 | 479 | 89 | 479 |
| EG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. | 0 | 427 | 16 | 427 | 47 | 427 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulum intestinal hemorrhagic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Primary progressive multiple sclerosis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abortion spontaneousa | Pregnancy, puerperium and perinatal conditions | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
The sponsor will work with the Investigators to determine how any manuscript or publication in a scientific journal is written and edited, the number and order of authors, the publication to which it will be submitted, and other related issues. The sponsor has final approval authority over all such issues. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583636 | eluxadoline |
Not provided
Not provided
Not provided
|
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| 41-64 years |
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| ≥65 years |
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| Black |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Not Hispanic or Latino |
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| Chi-square test statistic |
| 0.004 |
Significance level of 0.025 |
| Superiority |
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. |
| OG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. |
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| OG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. |
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| OG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. |
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