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The study was terminated early due to difficulty in enrollment and lack of clinical study drug access.
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| Name | Class |
|---|---|
| Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | UNKNOWN |
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The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.
RECD3126 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 52-week study to assess the efficacy and safety of rifaximin DR tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in participants with active moderate Crohn's disease.
Participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. Ileocolonoscopy will be performed on all participants at baseline, between Weeks 16 and 17 (end of the Induction Phase), and following completion of the 36-week Long Term Treatment Phase (Week 52).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin EIR 800 mg | Experimental | Participants will receive rifaximin EIR 400 milligrams (mg) tablets orally twice daily for 52 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching to rifaximin EIR tablets orally twice daily for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin EIR | Drug | Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16 | Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being less than or equal to (≤) 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | Week 16 |
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16 | Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | Week 16 |
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16 | Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16 | Clinical remission was defined as a CDAI score of less than 150 points at Week 16. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35802 | United States | |||
Participants were randomized in a 1:1 allocation to Rifaximin EIR 800 mg or Placebo at the beginning of the treatment period and were maintained on that treatment assignment for 16 weeks, followed by an open-label long-term active treatment extension of an additional 36 weeks.
A total of 81 participants were enrolled and randomized in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin EIR 800 mg | Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks. |
| FG001 | Placebo | Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2014 | Aug 15, 2019 |
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| Placebo | Drug | Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm. |
|
| Week 16 |
| Number of Participants With Endoscopic Response Between Week 16 and 17 | Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17. SES-CD scores were calculated from centrally-read digital video of ileocolonoscopies performed at baseline and between Week 16 and Week 17. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | Baseline, Week 16 to 17 |
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52 | Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | Week 52 |
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52 | Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | Week 52 |
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52 | Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | Week 52 |
| Number of Participants With Endoscopic Response at Week 52 | Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained at Week 52. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | Baseline, Week 52 |
| Week 16 |
| Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time | Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to each clinical visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the last 7 days prior to each clinic visit in ≥ 80% of the study visits during the 52-week treatment period, including Week 52. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | From Baseline to Week 52 |
| Number of Participants With SES-CD Score of 0 at Week 52 | SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | Week 52 |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Tucson | Arizona | 85712 | United States |
| Tucson | Arizona | 85741 | United States |
| Sherwood | Arkansas | 72120 | United States |
| Garden Grove | California | 92845 | United States |
| La Jolla | California | 92037 | United States |
| La Mirada | California | 90638 | United States |
| Laguna Hills | California | 92653 | United States |
| Los Angeles | California | 90045 | United States |
| Northridge | California | 91324 | United States |
| Oceanside | California | 92056 | United States |
| San Diego | California | 92103 | United States |
| Littleton | Colorado | 80120 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Boca Raton | Florida | 33428 | United States |
| Clearwater | Florida | 33756 | United States |
| Coral Gables | Florida | 33173 | United States |
| Hollywood | Florida | 33021 | United States |
| Inverness | Florida | 34452 | United States |
| Lauderdale Lakes | Florida | 33319 | United States |
| Maitland | Florida | 32751 | United States |
| Miami | Florida | 33136 | United States |
| Miami | Florida | 33144 | United States |
| Miami | Florida | 33173 | United States |
| Miami Springs | Florida | 33166 | United States |
| Orange Park | Florida | 32073 | United States |
| Orlando | Florida | 32803 | United States |
| Palm Harbor | Florida | 33781 | United States |
| Port Orange | Florida | 32127 | United States |
| Tampa | Florida | 33603 | United States |
| Athens | Georgia | 30606 | United States |
| Atlanta | Georgia | 30322 | United States |
| Atlanta | Georgia | 30338 | United States |
| Macon | Georgia | 31201 | United States |
| Chicago | Illinois | 60624 | United States |
| Evanston | Illinois | 60201 | United States |
| Iowa City | Iowa | 52242 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Shreveport | Louisiana | 71102 | United States |
| West Monroe | Louisiana | 71291 | United States |
| Hagerstown | Maryland | 21742 | United States |
| Hollywood | Maryland | 20636 | United States |
| Brockton | Massachusetts | 02302 | United States |
| Caro | Michigan | 48723 | United States |
| Stevensville | Michigan | 49127 | United States |
| Wyoming | Michigan | 49519 | United States |
| Plymouth | Minnesota | 55446 | United States |
| Ocean Springs | Mississippi | 39564 | United States |
| Tupelo | Mississippi | 60624 | United States |
| Bridgeton | Missouri | 63044 | United States |
| Creve Coeur | Missouri | 63141 | United States |
| Vineland | New Jersey | 08360 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10032 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| Kinston | North Carolina | 28501 | United States |
| Beavercreek | Ohio | 45440 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Columbus | Ohio | 43210 | United States |
| Kettering | Ohio | 45429 | United States |
| Lima | Ohio | 45806 | United States |
| Oklahoma City | Oklahoma | 73102 | United States |
| Portland | Oregon | 97210 | United States |
| Columbia | South Carolina | 29203 | United States |
| Fort Mill | South Carolina | 29707 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77036 | United States |
| Houston | Texas | 77099 | United States |
| Humble | Texas | 77338 | United States |
| San Antonio | Texas | 78229 | United States |
| Tyler | Texas | 75701 | United States |
| Ogden | Utah | 84405 | United States |
| West Jordan | Utah | 84088 | United States |
| West Valley City | Utah | 84120 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Richland | Washington | 99352 | United States |
| Intent-to-treat (ITT) Population | Received at least 1 dose of study drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin EIR 800 mg | Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks. |
| BG001 | Placebo | Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks. |
| BG002 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Crohn's Disease Activity Index (CDAI) Score | CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Simple Endoscopic Score for Crohn's Disease (SES-CD) | SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Duration of Disease | Duration of Crohn's disease at baseline was measured. | Mean | Standard Deviation | years |
|
| 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 | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16 | Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being less than or equal to (≤) 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 16 |
|
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| |||||||||||||||||||||||||||||
| Primary | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16 | Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 16 |
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| Primary | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16 | Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 16 |
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| Primary | Number of Participants With Endoscopic Response Between Week 16 and 17 | Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17. SES-CD scores were calculated from centrally-read digital video of ileocolonoscopies performed at baseline and between Week 16 and Week 17. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline, Week 16 to 17 |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52 | Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 52 |
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| Primary | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52 | Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 52 |
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| Primary | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52 | Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 52 |
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| Primary | Number of Participants With Endoscopic Response at Week 52 | Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained at Week 52. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline, Week 52 |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16 | Clinical remission was defined as a CDAI score of less than 150 points at Week 16. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time | Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to each clinical visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the last 7 days prior to each clinic visit in ≥ 80% of the study visits during the 52-week treatment period, including Week 52. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From Baseline to Week 52 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With SES-CD Score of 0 at Week 52 | SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. | ITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 52 |
|
|
Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
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 | Rifaximin EIR 800 mg | Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks. | 0 | 35 | 6 | 35 | 25 | 35 |
| EG001 | Placebo | Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks. | 0 | 45 | 9 | 45 | 25 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
The study was terminated early due to difficulty in enrollment and lack of clinical study drug access. The efficacy results are not considered definitive and are considered for exploratory purposes only.
Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc. | 908-927-0873 | lindsey.mathew@bauschhealth.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2019 | Sep 6, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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