Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001601-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eluxadoline 75 mg | Experimental | Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period. |
|
| Eluxadoline 100 mg | Experimental | Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period. |
|
| Placebo | Placebo Comparator | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 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 participants 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 participants 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. |
Not provided
Inclusion Criteria:
2. 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
Participant has documented weight loss within the past 6 months
Participant has nocturnal symptoms
Participant has a familial history of first-degree relatives with colon cancer
Participant has blood mixed with their stool (excluding blood from hemorrhoids).
3. Female participants must be:
Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
Abstinent, or
If sexually active, be practicing an effective method of birth control.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Furiex Research Site | Birmingham | Alabama | 35209 | 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 |
Not provided
Not provided
3356 participants were prescreened and entered into interactive voice response system for participation in the study. 1146 participants were randomized. One participant was unintentionally randomized twice and was assigned 2 different participant identification numbers due to participant trying to participate at more than 1 study center at once.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eluxadoline 75 mg | Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
| FG001 | Eluxadoline 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 and 30 (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 |
| 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 and 30/EOT |
| Birmingham |
| Alabama |
| 35242 |
| United States |
| Furiex Research Site | Decatur | Alabama | 35603 | United States |
| Furiex Research Site | Huntsville | Alabama | 35801 | United States |
| Furiex Research Site | Mobile | Alabama | 36608 | United States |
| Furiex Research Site | Montgomery | Alabama | 36109 | United States |
| Furiex Research Site | Sheffield | Alabama | 35660 | United States |
| Furiex Research Site | Tuscaloosa | Alabama | 35401 | United States |
| Furiex Research Site | Glendale | Arizona | 85306 | United States |
| Furiex Research Site | Glendale | Arizona | 85308 | United States |
| Furiex Research Site | Mesa | Arizona | 85206 | United States |
| Furiex Research Site | Phoenix | Arizona | 85023 | United States |
| Furiex Research Site | Phoenix | Arizona | 85032 | United States |
| Furiex Research Site | Tucson | Arizona | 85704 | United States |
| Furiex Research Site | Tucson | Arizona | 85712 | United States |
| Furiex Research Site | Jonesboro | Arkansas | 72401 | United States |
| Furiex Research Site | Little Rock | Arkansas | 72205 | United States |
| Furiex Research Site | Sherwood | Arkansas | 72120 | United States |
| Furiex Research Site | Anaheim | California | 92801 | United States |
| Furiex Research Site | Chula Vista | California | 91910 | United States |
| Furiex Research Site | Encinitas | California | 92024 | United States |
| Furiex Research Site | Garden Grove | California | 92840 | United States |
| Furiex Research Site | Huntington Beach | California | 92647 | United States |
| Furiex Research Site | Irvine | California | 92604 | United States |
| Furiex Research Site | La Mesa | California | 91942 | United States |
| Furiex Research Site | La Mirada | California | 90638 | United States |
| Furiex Research Site | Laguna Hills | California | 92653 | United States |
| Furiex Research Site | Lakewood | California | 90805 | United States |
| Furiex Research Site | Lincoln | California | 95648 | United States |
| Furiex Research Site | Loma Linda | California | 92354 | United States |
| Furiex Research Site | Lomita | California | 90717 | United States |
| Furiex Research Site | Long Beach | California | 90806 | United States |
| Furiex Research Site | Los Angeles | California | 90045 | United States |
| Furiex Research Site | Newport Beach | California | 92663 | United States |
| Furiex Research Site | North Hollywood | California | 91606 | United States |
| Furiex Research Site | Northridge | California | 91325 | United States |
| Furiex Research Site | Pasadena | California | 91105 | United States |
| Furiex Research Site | Sacramento | California | 95817 | United States |
| Furiex Research Site | San Diego | California | 92103 | United States |
| Furiex Research Site | San Diego | California | 92105 | United States |
| Furiex Research Site | Santa Ana | California | 92701 | United States |
| Furiex Research Site | Ventura | California | 93003 | United States |
| Furiex Research Site | Walnut Creek | California | 94598 | United States |
| Furiex Research Site | Denver | Colorado | 80211 | United States |
| Furiex Research Site | Denver | Colorado | 80246 | United States |
| Furiex Research Site | Boca Raton | Florida | 33428 | United States |
| Furiex Research Site | Boynton Beach | Florida | 33426 | United States |
| Furiex Research Site | Bradenton | Florida | 34208 | United States |
| Furiex Research Site | Brooksville | Florida | 34601 | United States |
| Furiex Research Site | Clearwater | Florida | 33759 | United States |
| Furiex Research Site | Cooper City | Florida | 33024 | United States |
| Furiex Research Site | Coral Springs | Florida | 33065 | United States |
| Furiex Research Site | Eustis | Florida | 32726 | United States |
| Furiex Research Site | Fort Lauderdale | Florida | 33308 | United States |
| Furiex Research Site | Hallandale | Florida | 33009 | United States |
| Furiex Research Site | Hialeah | Florida | 33016 | United States |
| Furiex Research Site | Jacksonville | Florida | 32205 | United States |
| Furiex Research Site | Jupiter | Florida | 33458 | United States |
| Furiex Research Site | Lauderdale Lakes | Florida | 33319 | United States |
| Furiex Research Site | Melbourne | Florida | 32901 | 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 | 33183 | United States |
| Furiex Research Site | Miramar | Florida | 33025 | United States |
| Furiex Research Site | New Port Richey | Florida | 34652 | United States |
| Furiex Research Site | Orlando | Florida | 32806 | United States |
| Furiex Research Site | Plant City | Florida | 33563 | United States |
| Furiex Research Site | Port Orange | Florida | 32127 | United States |
| Furiex Research Site | South Miami | Florida | 33143 | United States |
| Furiex Research Site | St. Petersburg | Florida | 33705 | United States |
| Furiex Research Site | St. Petersburg | Florida | 33709 | United States |
| Furiex Research Site | Tampa | Florida | 33607 | 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 | Alpharetta | Georgia | 30005 | United States |
| Furiex Research Site | Athens | Georgia | 30606 | United States |
| Furiex Research Site | Atlanta | Georgia | 30308 | United States |
| Furiex Research Site | Atlanta | Georgia | 30338 | United States |
| Furiex Research Site | Dunwoody | Georgia | 30338 | United States |
| Furiex Research Site | Lawrenceville | Georgia | 30046 | United States |
| Furiex Research Site | Macon | Georgia | 31201 | United States |
| Furiex Research Site | Marietta | Georgia | 30066 | United States |
| Furiex Research Site | Norcross | Georgia | 30092 | United States |
| Furiex Research Site | Savannah | Georgia | 31404 | United States |
| Furiex Research Site | Stockbridge | Georgia | 30281 | United States |
| Furiex Research Site | Boise | Idaho | 83704 | United States |
| Furiex Research Site | Eagle | Idaho | 83616 | United States |
| Furiex Research Site | Idaho Falls | Idaho | 83404 | United States |
| Furiex Research Site | Addison | Illinois | 60101 | United States |
| Furiex Research Site | Chicago | Illinois | 60612 | United States |
| Furiex Research Site | Chicago | Illinois | 60622 | United States |
| Furiex Research Site | Evergreen Park | Illinois | 60805 | United States |
| Furiex Research Site | Hammond | Illinois | 46324 | United States |
| Furiex Research Site | Springfield | Illinois | 62703 | United States |
| Furiex Research Site | Brownsburg | Indiana | 46112 | United States |
| Furiex Research Site | Evansville | Indiana | 47714 | United States |
| Furiex Research Site | Granger | Indiana | 46530 | United States |
| Furiex Research Site | Clive | Iowa | 50325 | United States |
| Furiex Research Site | Pratt | Kansas | 67124 | United States |
| Furiex Research Site | Shawnee Mission | Kansas | 66218 | United States |
| Furiex Research Site | Topeka | Kansas | 66606 | United States |
| Furiex Research Site | Lexington | Kentucky | 40503 | United States |
| Furiex Research Site | Lexington | Kentucky | 40504 | United States |
| Furiex Research Site | Owensboro | Kentucky | 42303 | United States |
| Furiex Research Site | Paducah | Kentucky | 42003 | United States |
| Furiex Research Site | Lake Charles | Louisiana | 70601 | United States |
| Furiex Research Site | Monroe | Louisiana | 71201 | United States |
| Furiex Research Site | Hagerstown | Maryland | 21742 | United States |
| Furiex Research Site | Hollywood | Maryland | 20636 | United States |
| Furiex Research Site | Boston | Massachusetts | 02115 | United States |
| Furiex Research Site | Boston | Massachusetts | 02131 | United States |
| Furiex Research Site | Brockton | Massachusetts | 02302 | United States |
| Furiex Research Site | Watertown | Massachusetts | 02472 | United States |
| Furiex Research Site | Ann Arbor | Michigan | 48106 | United States |
| Furiex Research Site | Bay City | Michigan | 48706 | United States |
| Furiex Research Site | Cadillac | Michigan | 49601 | United States |
| Furiex Research Site | Grand Rapids | Michigan | 49506 | United States |
| Furiex Research Site | Kalamazoo | Michigan | 49009 | United States |
| Furiex Research Site | Troy | Michigan | 48098 | United States |
| Furiex Research Site | Ypsilanti | Michigan | 48197 | United States |
| Furiex Research Site | Plymouth | Minnesota | 55446 | United States |
| Furiex Research Site | Biloxi | Mississippi | 39531 | United States |
| Furiex Research Site | City of Saint Peters | Missouri | 63376 | United States |
| Furiex Research Site | Hazelwood | Missouri | 63042 | United States |
| Furiex Research Site | St Louis | Missouri | 63122 | 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 | 59101 | United States |
| Furiex Research Site | Bellevue | Nebraska | 68005 | United States |
| Furiex Research Site | Elkhorn | Nebraska | 68022 | United States |
| Furiex Research Site | Lincoln | Nebraska | 68510 | United States |
| Furiex Research Site | Omaha | Nebraska | 68134 | United States |
| Furiex Research Site | Omaha | Nebraska | 68144 | United States |
| Furiex Research Site | Las Vegas | Nevada | 89123 | United States |
| Furiex Research Site | Reno | Nevada | 89511 | United States |
| Furiex Research Site | Lebanon | New Hampshire | 03756 | United States |
| Furiex Research Site | Blackwood | New Jersey | 08012 | United States |
| Furiex Research Site | Edison | New Jersey | 08817 | United States |
| Furiex Research Site | Elizabeth | New Jersey | 07201 | United States |
| Furiex Research Site | Marlton | New Jersey | 08053 | United States |
| Furiex Research Site | Albuquerque | New Mexico | 87102 | United States |
| Furiex Research Site | Albuquerque | New Mexico | 87108 | United States |
| Furiex Research Site | Albuquerque | New Mexico | 87109 | United States |
| Furiex Research Site | Flushing | New York | 11367 | United States |
| Furiex Research Site | Hollis | New York | 11423 | United States |
| Furiex Research Site | Mineola | New York | 11501 | United States |
| Furiex Research Site | New York | New York | 10016 | United States |
| Furiex Research Site | Chapel Hill | North Carolina | 27599 | United States |
| Furiex Research Site | Dunn | North Carolina | 28334 | United States |
| Furiex Research Site | Greensboro | North Carolina | 27403 | United States |
| Furiex Research Site | Huntersville | North Carolina | 28078 | United States |
| Furiex Research Site | Kinston | North Carolina | 28501 | United States |
| Furiex Research Site | Wilmington | North Carolina | 28403 | United States |
| Furiex Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Furiex Research Site | Winston-Salem | North Carolina | 27106 | United States |
| Furiex Research Site | Akron | Ohio | 44302 | United States |
| Furiex Research Site | Beavercreek | Ohio | 45431 | United States |
| Furiex Research Site | Cincinnati | Ohio | 45224 | United States |
| Furiex Research Site | Cincinnati | Ohio | 45242 | United States |
| Furiex Research Site | Cincinnati | Ohio | 45245 | United States |
| Furiex Research Site | Cincinnati | Ohio | 45267 | United States |
| Furiex Research Site | Cleveland | Ohio | 44122 | United States |
| Furiex Research Site | Columbus | Ohio | 43212 | United States |
| Furiex Research Site | Columbus | Ohio | 43214 | United States |
| Furiex Research Site | Columbus | Ohio | 43235 | United States |
| Furiex Research Site | Dayton | Ohio | 45432 | United States |
| Furiex Research Site | Dayton | Ohio | 45439 | United States |
| Furiex Research Site | Groveport | Ohio | 43125 | United States |
| Furiex Research Site | Kettering | Ohio | 45429 | United States |
| Furiex Research Site | Lima | Ohio | 45806 | United States |
| Furiex Research Site | Tiffin | Ohio | 44883 | United States |
| Furiex Research Site | Toledo | Ohio | 43615 | United States |
| Furiex Research Site | Norman | Oklahoma | 73071 | United States |
| Furiex Research Site | Oklahoma City | Oklahoma | 73102 | United States |
| Furiex Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Furiex Research Site | Portland | Oregon | 97210 | United States |
| Furiex Research Site | Salem | Oregon | 97301 | United States |
| Furiex Research Site | Carnegie | Pennsylvania | 15106 | United States |
| Furiex Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Furiex Research Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Furiex Research Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Furiex Research Site | Scottdale | Pennsylvania | 15683 | United States |
| Furiex Research Site | Uniontown | Pennsylvania | 15401 | United States |
| Furiex Research Site | Warwick | Rhode Island | 02888 | United States |
| Furiex Research Site | Anderson | South Carolina | 29621 | United States |
| Furiex Research Site | Columbia | South Carolina | 29201 | United States |
| Furiex Research Site | Columbia | South Carolina | 29203 | United States |
| Furiex Research Site | Columbia | South Carolina | 29204 | United States |
| Furiex Research Site | Easley | South Carolina | 29640 | United States |
| Furiex Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Furiex Research Site | North Myrtle Beach | South Carolina | 29582 | United States |
| Furiex Research Site | Rapid City | South Dakota | 57702 | United States |
| Furiex Research Site | Athens | Tennessee | 37303 | United States |
| Furiex Research Site | Chattanooga | Tennessee | 37404 | United States |
| Furiex Research Site | Columbia | Tennessee | 38401 | United States |
| Furiex Research Site | Jackson | Tennessee | 38305 | United States |
| Furiex Research Site | Knoxville | Tennessee | 37919 | United States |
| Furiex Research Site | Smyrna | Tennessee | 37167 | United States |
| Furiex Research Site | Austin | Texas | 78745 | United States |
| Furiex Research Site | Beaumont | Texas | 77701 | United States |
| Furiex Research Site | Bedford | Texas | 76021 | United States |
| Furiex Research Site | Corsicana | Texas | 75110 | United States |
| Furiex Research Site | Dallas | Texas | 75218 | United States |
| Furiex Research Site | Dallas | Texas | 75225 | United States |
| Furiex Research Site | Fort Worth | Texas | 76133 | United States |
| Furiex Research Site | Frisco | Texas | 75035 | United States |
| Furiex Research Site | Houston | Texas | 77008 | United States |
| Furiex Research Site | Houston | Texas | 77043 | United States |
| Furiex Research Site | Houston | Texas | 77062 | United States |
| Furiex Research Site | Humble | Texas | 77338 | United States |
| Furiex Research Site | Hurst | Texas | 76054 | United States |
| Furiex Research Site | San Antonio | Texas | 78215 | United States |
| Furiex Research Site | San Antonio | Texas | 78229 | United States |
| Furiex Research Site | San Antonio | Texas | 78258 | United States |
| Furiex Research Site | Bountiful | Utah | 84010 | United States |
| Furiex Research Site | Salt Lake City | Utah | 84124 | United States |
| Furiex Research Site | West Valley City | Utah | 84120 | United States |
| Furiex Research Site | Burlington | Vermont | 05401 | United States |
| Furiex Research Site | Alexandria | Virginia | 22304 | United States |
| Furiex Research Site | Christiansburg | Virginia | 24073 | United States |
| Furiex Research Site | Midlothian | Virginia | 23114 | United States |
| Furiex Research Site | Norfolk | Virginia | 23502 | United States |
| Furiex Research Site | Richmond | Virginia | 23233 | United States |
| Furiex Research Site | Richmond | Virginia | 23235 | United States |
| Furiex Research Site | Charleston | West Virginia | 25304 | United States |
| Furiex Research Site | Monroe | Wisconsin | 53566 | United States |
| Furiex Research Site | Kelowna | British Columbia | V1Y 3G8 | Canada |
| Furiex Research Site | St. John's | Newfoundland and Labrador | A1E 2E2 | Canada |
| Furiex Research Site | Burlington | Ontario | L7M 4Y1 | Canada |
| Furiex Research Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| Furiex Research Site | Hawkesbury | Ontario | K6A 1A1 | Canada |
| Furiex Research Site | London | Ontario | N5W 6A2 | Canada |
| Furiex Research Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Furiex Research Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Furiex Research Site | Toronto | Ontario | M6H 3M1 | Canada |
| Furiex Research Site | Vaughan | Ontario | L4L 4Y7 | Canada |
| Furiex Research Site | San Juan | 00926-2832 | Puerto Rico |
| Furiex Research Site | Chestfield | Kent | CT5 3QS | United Kingdom |
| Furiex Research Site | Blackpool | Lancashire | FY4 3AD | United Kingdom |
| Furiex Research Site | Birmingham | B15 2TH | United Kingdom |
| Furiex Research Site | County Durham | DL14 6AD | United Kingdom |
| Furiex Research Site | Coventry | CV2 2DX | United Kingdom |
| Furiex Research Site | Durham | DH1 5TW | United Kingdom |
| Furiex Research Site | Edinburgh | EH4 2XH | United Kingdom |
| Furiex Research Site | Manchester | M23 9LT | United Kingdom |
| Furiex Research Site | Sheffield | S10 2JF | United Kingdom |
| Furiex Research Site | Wigan | WN1 2NN | 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. |
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
| FG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
| Attended Week 12 Visit |
|
| Attended Week 26 Visit |
|
| Participated in Blinded-Placebo Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled set included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eluxadoline 75 mg | Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
| BG001 | Eluxadoline 100 mg | Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
| BG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo 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 |
|
| 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 participants 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. | Intention-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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 participants 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 and 30 (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. | 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. | 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. | 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. | 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. | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Urgency Episodes Per Day | Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment. | 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 | 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. | 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 and 30/EOT |
|
From first dose of study drug up to 30 weeks
Safety Set: all participants who received at least 1 dose of drug per actual treatment received. 1 participant in 100 mg arm received 75 mg, 2 participants in Placebo arm received eluxadoline 75 mg and 100 mg. AEs for each period were analyzed separately. In the Other AE section, a result of 0 in an arm means the ≥5% threshold was not met.
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 (Treatment Period) | Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period. | 0 | 379 | 9 | 379 | 97 | 379 |
| EG001 | Eluxadoline 100 mg (Treatment Period) | Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period. | 0 | 380 | 14 | 380 | 97 | 380 |
| EG002 | Placebo (Treatment Period) | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period. | 0 | 381 | 8 | 381 | 69 | 381 |
| EG003 | Eluxadoline 75 mg (Blinded-Placebo Period) | Participants who received eluxadoline 75 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks. | 0 | 246 | 0 | 246 | 0 | 246 |
| EG004 | Eluxadoline 100 mg (Blinded-Placebo Period) | Participants who received eluxadoline 100 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks. | 0 | 253 | 0 | 253 | 0 | 253 |
| EG005 | Placebo (Blinded-Placebo Period) | Participants who received placebo matching tablets in treatment period were administered with placebo orally, twice daily for next 4 weeks. | 0 | 272 | 0 | 272 | 0 | 272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Colitis ischemic | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Enterocolitis infections | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Non-cardiac pain | General disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
| |
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
| |
| ECG T wave abnormal | Investigations | MedDRA version 11.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 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 |
| D003108 | Colonic Diseases |
| D003109 | Colonic Diseases, Functional |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D003112 | Colonic Pseudo-Obstruction |
| D003967 | Diarrhea |
| D012817 | Signs and Symptoms, Digestive |
| ID | Term |
|---|---|
| D007418 | Intestinal Pseudo-Obstruction |
| D045823 | Ileus |
| D007415 | Intestinal Obstruction |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C583636 | eluxadoline |
Not provided
Not provided
Not provided
| 41-64 years |
|
| ≥65 years |
|
| Male |
|
| Chi-square test statistic |
| <0.001 |
Significance level of 0.025 |
| Superiority |
| Eluxadoline 100 mg |
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
| OG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
|
|
|
| Placebo |
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
|
|
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
| OG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
|
|
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
| OG002 | Placebo | Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
|
|
| Placebo |
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
|
|
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
|
|