Trial Outcomes & Findings for One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease (NCT NCT02240121)
NCT ID: NCT02240121
Last Updated: 2019-09-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Week 52
Results posted on
2019-09-10
Participant Flow
A total of 80 participants were enrolled and randomized in this study.
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.
Participant milestones
| Measure |
Rifaximin EIR 800 mg
Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks.
|
Placebo
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
Reasons for withdrawal
| Measure |
Rifaximin EIR 800 mg
Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks.
|
Placebo
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Change in protocol interpretation
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Site closed
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Other than specified
|
1
|
3
|
Baseline Characteristics
One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Crohn's Disease Activity Index (CDAI) Score
|
298.5 units on a scale
STANDARD_DEVIATION 56.89 • n=5 Participants
|
296.9 units on a scale
STANDARD_DEVIATION 70.86 • n=7 Participants
|
297.7 units on a scale
STANDARD_DEVIATION 63.85 • n=5 Participants
|
|
Simple Endoscopic Score for Crohn's Disease (SES-CD)
|
12.7 units on a scale
STANDARD_DEVIATION 5.85 • n=5 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 6.40 • n=7 Participants
|
13.3 units on a scale
STANDARD_DEVIATION 6.11 • n=5 Participants
|
|
Duration of Disease
|
9.8 years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 7.71 • n=7 Participants
|
9.7 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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). 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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16
|
18 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16 to 17Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants With Endoscopic Response Between Week 16 and 17
|
16 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52
|
16 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants With Endoscopic Response at Week 52
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=40 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants With SES-CD Score of 0 at Week 52
|
2 Participants
|
3 Participants
|
Adverse Events
Rifaximin EIR 800 mg
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rifaximin EIR 800 mg
n=40 participants at risk
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 participants at risk
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
General disorders
Pyrexia
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Infections and infestations
Anal abscess
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
Perirectal abscess
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
Anal fistula
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Gastrointestinal disorders
Crohn's disease
|
7.5%
3/40 • 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.
|
7.5%
3/40 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Surgical and medical procedures
Cholecystectomy
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
Ileus paralytic
|
2.5%
1/40 • 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.
|
0.00%
0/40 • 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.
|
Other adverse events
| Measure |
Rifaximin EIR 800 mg
n=40 participants at risk
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=40 participants at risk
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
4/40 • 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.
|
2.5%
1/40 • 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.
|
|
Ear and labyrinth disorders
Vertigo positional
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
5/40 • 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.
|
5.0%
2/40 • 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.
|
|
Gastrointestinal disorders
Crohn's disease
|
15.0%
6/40 • 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.
|
20.0%
8/40 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
3/40 • 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.
|
5.0%
2/40 • 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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • 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.
|
15.0%
6/40 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • 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.
|
15.0%
6/40 • 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.
|
|
General disorders
Fatigue
|
2.5%
1/40 • 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.
|
7.5%
3/40 • 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.
|
|
General disorders
Pyrexia
|
7.5%
3/40 • 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.
|
5.0%
2/40 • 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.
|
|
Infections and infestations
Bronchitis
|
7.5%
3/40 • 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.
|
0.00%
0/40 • 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.
|
|
Infections and infestations
Clostridium difficile infection
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Infections and infestations
Cystitis
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
Folliculitis
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • 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.
|
7.5%
3/40 • 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.
|
|
Infections and infestations
Hordeolum
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
4/40 • 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.
|
12.5%
5/40 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40 • 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.
|
7.5%
3/40 • 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.
|
|
Infections and infestations
Urinary tract infection
|
15.0%
6/40 • 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.
|
0.00%
0/40 • 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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • 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.
|
15.0%
6/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • 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.
|
12.5%
5/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • 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.
|
7.5%
3/40 • 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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
Additional Information
Director of Clinical Operations
Bausch Health Americas, Inc.
Phone: 908-927-0873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER