Irritable Bowel Syndrome Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea
| Verified date | September 2019 |
| Source | Furiex Pharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).
| Status | Completed |
| Enrollment | 807 |
| Est. completion date | July 14, 2011 |
| Est. primary completion date | July 14, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Key Inclusion Criteria: - Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea - Female patients must be: - postmenopausal, defined as amenorrhea 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. Key Exclusion Criteria: - Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS - Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease - Patient has a history of diverticulitis within 6 months prior to Prescreening - Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states. Other protocol-specific eligibility criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Furiex Research Site | Akron | Ohio |
| United States | Furiex Research Site | Albuquerque | New Mexico |
| United States | Furiex Research Site | Albuquerque | New Mexico |
| United States | Furiex Research Site | Alexandria | Virginia |
| United States | Furiex Research Site | Aliso Viejo | California |
| United States | Furiex Research Site | Anaheim | California |
| United States | Furiex Research Site | Anderson | Indiana |
| United States | Furiex Research Site | Anderson | South Carolina |
| United States | Furiex Research Site | Annapolis | Maryland |
| United States | Furiex Research Site | Anniston | Alabama |
| United States | Furiex Research Site | Atco | New Jersey |
| United States | Furiex Research Site | Atlanta | Georgia |
| United States | Furiex Research Site | Atlanta | Georgia |
| United States | Furiex Research Site | Austin | Texas |
| United States | Furiex Research Site | Aventura | Florida |
| United States | Furiex Research Site | Azusa | California |
| United States | Furiex Research Site | Beachwood | Ohio |
| United States | Furiex Research Site | Beavercreek | Ohio |
| United States | Furiex Research Site | Bedford | Texas |
| United States | Furiex Research Site | Bellevue | Nebraska |
| United States | Furiex Research Site | Billings | Montana |
| United States | Furiex Research Site | Binghamton | New York |
| United States | Furiex Research Site | Birmingham | Alabama |
| United States | Furiex Research Site | Birmingham | Alabama |
| United States | Furiex Research Site | Blackwood | New Jersey |
| United States | Furiex Research Site | Bloomington | Indiana |
| United States | Furiex Research Site | Boca Raton | Florida |
| United States | Furiex Research Site | Boca Raton | Florida |
| United States | Furiex Research Site | Boise | Idaho |
| United States | Furiex Research Site | Boise | Idaho |
| United States | Furiex Research Site | Boone | North Carolina |
| United States | Furiex Research Site | Boston | Massachusetts |
| United States | Furiex Research Site | Boston | Massachusetts |
| United States | Furiex Research Site | Boston | Massachusetts |
| United States | Furiex Research Site | Bowling Green | Kentucky |
| United States | Furiex Research Site | Bozeman | Montana |
| United States | Furiex Research Site | Bradenton | Florida |
| United States | Furiex Research Site | Brandon | Florida |
| United States | Furiex Research Site | Bristol | Connecticut |
| United States | Furiex Research Site | Bristol | Tennessee |
| United States | Furiex Research Site | Brockton | Massachusetts |
| United States | Furiex Research Site | Brooklyn | New York |
| United States | Furiex Research Site | Brooklyn | New York |
| United States | Furiex Research Site | Burbank | California |
| United States | Furiex Research Site | Carlsbad | California |
| United States | Furiex Research Site | Champaign | Illinois |
| United States | Furiex Research Site | Chandler | Arizona |
| United States | Furiex Research Site | Chapel Hill | North Carolina |
| United States | Furiex Research Site | Charlotte | North Carolina |
| United States | Furiex Research Site | Charlotte | North Carolina |
| United States | Furiex Research Site | Chaska | Minnesota |
| United States | Furiex Research Site | Chattanooga | Tennessee |
| United States | Furiex Research Site | Chattanooga | Tennessee |
| United States | Furiex Research Site | Chesapeake | Virginia |
| United States | Furiex Research Site | Chesterfield | Michigan |
| United States | Furiex Research Site | Chevy Chase | Maryland |
| United States | Furiex Research Site | Chicago | Illinois |
| United States | Furiex Research Site | Chipley | Florida |
| United States | Furiex Research Site | Christiansburg | Virginia |
| United States | Furiex Research Site | Cincinnati | Ohio |
| United States | Furiex Research Site | Cleveland | Ohio |
| United States | Furiex Research Site | Colleyville | Texas |
| United States | Furiex Research Site | Colorado Springs | Colorado |
| United States | Furiex Research Site | Colorado Springs | Colorado |
| United States | Furiex Research Site | Colorado Springs | Colorado |
| United States | Furiex Research Site | Colorado Springs | Colorado |
| United States | Furiex Research Site | Columbia | South Carolina |
| United States | Furiex Research Site | Columbia | South Carolina |
| United States | Furiex Research Site | Columbus | Ohio |
| United States | Furiex Research Site | Columbus | Ohio |
| United States | Furiex Research Site | Columbus | Georgia |
| United States | Furiex Research Site | Cumberland | Rhode Island |
| United States | Furiex Research Site | Danville | Virginia |
| United States | Furiex Research Site | Dayton | Ohio |
| United States | Furiex Research Site | DeLand | Florida |
| United States | Furiex Research Site | Delray Beach | Florida |
| United States | Furiex Research Site | Denver | Colorado |
| United States | Furiex Research Site | Denver | Colorado |
| United States | Furiex Research Site | Dingmans Ferry | Pennsylvania |
| United States | Furiex Research Site | Doral | Florida |
| United States | Furiex Research Site | Dothan | Alabama |
| United States | Furiex Research Site | Duluth | Georgia |
| United States | Furiex Research Site | East Providence | Rhode Island |
| United States | Furiex Research Site | El Paso | Texas |
| United States | Furiex Research Site | Elizabeth | New Jersey |
| United States | Furiex Research Site | Encinitas | California |
| United States | Furiex Research Site | Evansville | Indiana |
| United States | Furiex Research Site | Fairfax | Virginia |
| United States | Furiex Research Site | Fargo | North Dakota |
| United States | Furiex Research Site | Fargo | North Dakota |
| United States | Furiex Research Site | Fayetteville | North Carolina |
| United States | Furiex Research Site | Fort Lauderdale | Florida |
| United States | Furiex Research Site | Fort Worth | Texas |
| United States | Furiex Research Site | Fort Worth | Texas |
| United States | Furiex Research Site | Franklin | Ohio |
| United States | Furiex Research Site | Garden Grove | California |
| United States | Furiex Research Site | Garden Grove | California |
| United States | Furiex Research Site | Germantown | Tennessee |
| United States | Furiex Research Site | Glendale | Arizona |
| United States | Furiex Research Site | Grand Prairie | Texas |
| United States | Furiex Research Site | Grapevine | Texas |
| United States | Furiex Research Site | Great Neck | New York |
| United States | Furiex Research Site | Great Neck | New York |
| United States | Furiex Research Site | Greensboro | North Carolina |
| United States | Furiex Research Site | Greensboro | North Carolina |
| United States | Furiex Research Site | Greenville | North Carolina |
| United States | Furiex Research Site | Greer | South Carolina |
| United States | Furiex Research Site | Harrisburg | North Carolina |
| United States | Furiex Research Site | Henderson | Nevada |
| United States | Furiex Research Site | Hermitage | Pennsylvania |
| United States | Furiex Research Site | Hialeah | Florida |
| United States | Furiex Research Site | Hialeah | Florida |
| United States | Furiex Research Site | Hickory | North Carolina |
| United States | Furiex Research Site | Hickory | North Carolina |
| United States | Furiex Research Site | High Point | North Carolina |
| United States | Furiex Research Site | Hollywood | Maryland |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Houston | Texas |
| United States | Furiex Research Site | Huntsville | Alabama |
| United States | Furiex Research Site | Huntsville | Alabama |
| United States | Furiex Research Site | Hurst | Texas |
| United States | Furiex Research Site | Hyannis | Massachusetts |
| United States | Furiex Research Site | Idaho Falls | Idaho |
| United States | Furiex Research Site | Indianapolis | Indiana |
| United States | Furiex Research Site | Indianapolis | Indiana |
| United States | Furiex Research Site | Indianapolis | Indiana |
| United States | Furiex Research Site | Inglewood | California |
| United States | Furiex Research Site | Interlochen | Michigan |
| United States | Furiex Research Site | Inverness | Florida |
| United States | Furiex Research Site | Irving | Texas |
| United States | Furiex Research Site | Jackson | Tennessee |
| United States | Furiex Research Site | Jackson | Mississippi |
| United States | Furiex Research Site | Jacksonville | Florida |
| United States | Furiex Research Site | Jacksonville | Florida |
| United States | Furiex Research Site | Jacksonville | North Carolina |
| United States | Furiex Research Site | Jenkintown | Pennsylvania |
| United States | Furiex Research Site | Johnson City | Tennessee |
| United States | Furiex Research Site | Jonesboro | Arkansas |
| United States | Furiex Research Site | Jupiter | Florida |
| United States | Furiex Research Site | Kalamazoo | Michigan |
| United States | Furiex Research Site | Kingsport | Tennessee |
| United States | Furiex Research Site | Kissimmee | Florida |
| United States | Furiex Research Site | Laguna Hills | California |
| United States | Furiex Research Site | Lake Jackson | Texas |
| United States | Furiex Research Site | Lakewood | Colorado |
| United States | Furiex Research Site | Lancaster | Pennsylvania |
| United States | Furiex Research Site | Lansdale | Pennsylvania |
| United States | Furiex Research Site | Largo | Florida |
| United States | Furiex Research Site | Las Vegas | Nevada |
| United States | Furiex Research Site | Las Vegas | Nevada |
| United States | Furiex Research Site | Lauderdale Lakes | Florida |
| United States | Furiex Research Site | Laurel | Maryland |
| United States | Furiex Research Site | Lenexa | Kansas |
| United States | Furiex Research Site | Lexington | Kentucky |
| United States | Furiex Research Site | Little Rock | Arkansas |
| United States | Furiex Research Site | Littleton | Colorado |
| United States | Furiex Research Site | Logan | Utah |
| United States | Furiex Research Site | Long Beach | California |
| United States | Furiex Research Site | Los Angeles | California |
| United States | Furiex Research Site | Los Angeles | California |
| United States | Furiex Research Site | Louisville | Kentucky |
| United States | Furiex Research Site | Lutherville | Maryland |
| United States | Furiex Research Site | Macon | Georgia |
| United States | Furiex Research Site | Madison | Wisconsin |
| United States | Furiex Research Site | Marietta | Georgia |
| United States | Furiex Research Site | Marlton | New Jersey |
| United States | Furiex Research Site | Marshall | Texas |
| United States | Furiex Research Site | Melbourne | Florida |
| United States | Furiex Research Site | Mentor | Ohio |
| United States | Furiex Research Site | Meridian | Idaho |
| United States | Furiex Research Site | Mesa | Arizona |
| United States | Furiex Research Site | Metairie | Louisiana |
| United States | Furiex Research Site | Mexico | Missouri |
| United States | Furiex Research Site | Miami | Florida |
| United States | Furiex Research Site | Miami | Florida |
| United States | Furiex Research Site | Miami | Florida |
| United States | Furiex Research Site | Miamisburg | Ohio |
| United States | Furiex Research Site | Mill Creek | Washington |
| United States | Furiex Research Site | Milwaukee | Wisconsin |
| United States | Furiex Research Site | Mineola | New York |
| United States | Furiex Research Site | Mission | Kansas |
| United States | Furiex Research Site | Mobile | Alabama |
| United States | Furiex Research Site | Monroe | Louisiana |
| United States | Furiex Research Site | Montgomery | Alabama |
| United States | Furiex Research Site | Morristown | New Jersey |
| United States | Furiex Research Site | Morton | Illinois |
| United States | Furiex Research Site | Mount Pleasant | South Carolina |
| United States | Furiex Research Site | Murietta | California |
| United States | Furiex Research Site | Nampa | Idaho |
| United States | Furiex Research Site | Naples | Florida |
| United States | Furiex Research Site | Naples | Florida |
| United States | Furiex Research Site | Nashville | Tennessee |
| United States | Furiex Research Site | Nashville | Tennessee |
| United States | Furiex Research Site | New Bern | North Carolina |
| United States | Furiex Research Site | New Port Richey | Florida |
| United States | Furiex Research Site | New Port Richey | Florida |
| United States | Furiex Research Site | New Smyrna Beach | Florida |
| United States | Furiex Research Site | New York | New York |
| United States | Furiex Research Site | Newnan | Georgia |
| United States | Furiex Research Site | Newton | Pennsylvania |
| United States | Furiex Research Site | Norman | Oklahoma |
| United States | Furiex Research Site | Norman | Oklahoma |
| United States | Furiex Research Site | North Richland Hills | Texas |
| United States | Furiex Research Site | Novi | Michigan |
| United States | Furiex Research Site | Oakland | California |
| United States | Furiex Research Site | Odessa | Texas |
| United States | Furiex Research Site | Ogden | Utah |
| United States | Furiex Research Site | Oklahoma City | Oklahoma |
| United States | Furiex Research Site | Oklahoma City | Oklahoma |
| United States | Furiex Research Site | Omaha | Nebraska |
| United States | Furiex Research Site | Omaha | Nebraska |
| United States | Furiex Research Site | Opelousas | Louisiana |
| United States | Furiex Research Site | Orange | California |
| United States | Furiex Research Site | Orlando | Florida |
| United States | Furiex Research Site | Overland Park | Kansas |
| United States | Furiex Research Site | Overland Park | Kansas |
| United States | Furiex Research Site | Pell City | Alabama |
| United States | Furiex Research Site | Phoenix | Arizona |
| United States | Furiex Research Site | Phoenix | Arizona |
| United States | Furiex Research Site | Phoenix | Arizona |
| United States | Furiex Research Site | Plano | Texas |
| United States | Furiex Research Site | Plantation | Florida |
| United States | Furiex Research Site | Port Orange | Florida |
| United States | Furiex Research Site | Prince Frederick | Maryland |
| United States | Furiex Research Site | Raleigh | North Carolina |
| United States | Furiex Research Site | Raleigh | North Carolina |
| United States | Furiex Research Site | Rapid City | South Dakota |
| United States | Furiex Research Site | Rockville | Maryland |
| United States | Furiex Research Site | Rome | Georgia |
| United States | Furiex Research Site | Sacramento | California |
| United States | Furiex Research Site | Saint Louis | Missouri |
| United States | Furiex Research Site | Saint Peters | Missouri |
| United States | Furiex Research Site | Saint Petersburg | Florida |
| United States | Furiex Research Site | Salt Lake City | Utah |
| United States | Furiex Research Site | Salt Lake City | Utah |
| United States | Furiex Research Site | San Antonio | Texas |
| United States | Furiex Research Site | San Antonio | Texas |
| United States | Furiex Research Site | San Antonio | Texas |
| United States | Furiex Research Site | San Antonio | Texas |
| United States | Furiex Research Site | San Antonio | Texas |
| United States | Furiex Research Site | San Carlos | California |
| United States | Furiex Research Site | San Diego | California |
| United States | Furiex Research Site | San Diego | California |
| United States | Furiex Research Site | Sandy Springs | Georgia |
| United States | Furiex Research Site | Savannah | Georgia |
| United States | Furiex Research Site | Sayre | Pennsylvania |
| United States | Furiex Research Site | Searcy | Arkansas |
| United States | Furiex Research Site | Sherwood | Arkansas |
| United States | Furiex Research Site | Shreveport | Louisiana |
| United States | Furiex Research Site | Shreveport | Louisiana |
| United States | Furiex Research Site | South Bound Brook | New Jersey |
| United States | Furiex Research Site | South Jordan | Utah |
| United States | Furiex Research Site | South Miami | Florida |
| United States | Furiex Research Site | Springfield | Massachusetts |
| United States | Furiex Research Site | Springfield | Ohio |
| United States | Furiex Research Site | Sugar Land | Texas |
| United States | Furiex Research Site | Sugar Land | Texas |
| United States | Furiex Research Site | Tampa | Florida |
| United States | Furiex Research Site | Tampa | Florida |
| United States | Furiex Research Site | Tempe | Arizona |
| United States | Furiex Research Site | Tempe | Arizona |
| United States | Furiex Research Site | Thornton | Colorado |
| United States | Furiex Research Site | Topeka | Kansas |
| United States | Furiex Research Site | Troy | Michigan |
| United States | Furiex Research Site | Tucson | Arizona |
| United States | Furiex Research Site | Tucson | Arizona |
| United States | Furiex Research Site | Tupelo | Mississippi |
| United States | Furiex Research Site | Uniontown | Pennsylvania |
| United States | Furiex Research Site | Vineland | New Jersey |
| United States | Furiex Research Site | Virginia Beach | Virginia |
| United States | Furiex Research Site | Wadsworth | Ohio |
| United States | Furiex Research Site | Warwick | Rhode Island |
| United States | Furiex Research Site | Washington | Pennsylvania |
| United States | Furiex Research Site | Waterbury | Connecticut |
| United States | Furiex Research Site | Webster | Texas |
| United States | Furiex Research Site | West Jordan | Utah |
| United States | Furiex Research Site | West Valley City | Utah |
| United States | Furiex Research Site | Wichita | Kansas |
| United States | Furiex Research Site | Wilmington | North Carolina |
| United States | Furiex Research Site | Winston-Salem | North Carolina |
| United States | Furiex Research Site | Winston-Salem | North Carolina |
| United States | Furiex Research Site | Yukon | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Furiex Pharmaceuticals, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4 | Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by =30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 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. | Baseline (Week prior to Randomization) to Week 4 | |
| Primary | Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12 | Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by =30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 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. | Baseline (Week prior to Randomization) to Week 12 | |
| Secondary | Change From Baseline in the Weekly Pain Scores | The participant recorded their worst daily pain score in a diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement. | Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12 | |
| Secondary | Change From Baseline in Weekly BSS Scores | The patient recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=hard stool to 7=watery diarrhea. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement. | Baseline (Week prior to Randomization) to Weeks 4, 8, and 12 | |
| Secondary | Change From Baseline in the Number of Daily Bowel Movements | Participants recorded the number of bowel movements in a daily diary at the same time each day. The number of daily bowel movements over the previous week were averaged. A negative change from Baseline indicates improvement. | Baseline (Week prior to Randomization) to Weeks 4, 8, and 12 | |
| Secondary | Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time | Responders were participants that met both of the following criteria on the same week for at least 50% of time on study: 1) average of daily pain scores over the past week improved by =30% compared with baseline average in pain score, 2) =50% reduction in the number of days over the past week with a BSS score =5 compared with Baseline. Participants must also have had at least 5/7 days diary entry to be considered a responder for that week. Abdominal pain was assessed on an 11-point scale where a score of 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps to 7=watery with no solid pieces. Response rates (percentage of participants) are based on model estimates from the logistic regression. | Baseline (Week Prior to Randomization) to Weeks 1-12 |
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