Trial Outcomes & Findings for A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans (NCT NCT01542541)
NCT ID: NCT01542541
Last Updated: 2017-12-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Day 2
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Rifaximin
Rifaximin: 550mg BID for 2 days
|
Control
Randomly-selected matched PET-CT scans performed on same day as intervention group.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
Baseline characteristics by cohort
| Measure |
Rifaximin
n=38 Participants
Rifaximin: 550mg BID for 2 days
|
Control
n=30 Participants
Randomly-selected matched PET-CT scans performed on same day as intervention group.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 19 • n=5 Participants
|
56 years
STANDARD_DEVIATION 19 • n=7 Participants
|
56 years
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
30 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2Outcome measures
| Measure |
Rifaximin
n=30 Participants
Rifaximin: 550mg BID for 2 days
|
Control
n=30 Participants
Randomly-selected matched PET-CT scans performed on same day as intervention group.
|
|---|---|---|
|
SUVmax of FDG in Each Colonic Segment
|
4.6 SUV
Standard Deviation 2.3
|
4.3 SUV
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Day 2Outcome measures
| Measure |
Rifaximin
n=30 Participants
Rifaximin: 550mg BID for 2 days
|
Control
n=30 Participants
Randomly-selected matched PET-CT scans performed on same day as intervention group.
|
|---|---|---|
|
SUVavg in Each Colonic Segment
|
1.6 SUV
Standard Deviation 0.9
|
1.8 SUV
Standard Deviation 0.9
|
Adverse Events
Rifaximin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60