Trial Outcomes & Findings for Cheno Effect on Transit in Health and IBS-C (NCT NCT00912301)
NCT ID: NCT00912301
Last Updated: 2012-07-02
Results Overview
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
COMPLETED
PHASE2
36 participants
after 4 days of treatment
2012-07-02
Participant Flow
Participants were enrolled between April 17 and November 20, 2009 from 150 mile geographical area around Mayo Clinic, Rochester, MN.
40 patients signed informed consent, but 3 failed screening due to presence of evacuation disorder, and 1 withdrew prior to study due to illness.
Participant milestones
| Measure |
NaCDC 500 mg
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cheno Effect on Transit in Health and IBS-C
Baseline characteristics by cohort
| Measure |
NaCDC 500 mg
n=11 Participants
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 Participants
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 Participants
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
38.3 years
STANDARD_DEVIATION 3.3 • n=99 Participants
|
46.1 years
STANDARD_DEVIATION 2.6 • n=107 Participants
|
40.8 years
STANDARD_DEVIATION 2.3 • n=206 Participants
|
42 years
STANDARD_DEVIATION 10 • n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
13 participants
n=206 Participants
|
36 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: after 4 days of treatmentThe scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Outcome measures
| Measure |
NaCDC 500 mg
n=11 Participants
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 Participants
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 Participants
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Colonic Geometric Center at 24 Hours (GC24)
|
3.1 units on a scale
Standard Deviation 0.4
|
3.5 units on a scale
Standard Deviation 0.4
|
2.2 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: after 4 days of treatmentThe scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Outcome measures
| Measure |
NaCDC 500 mg
n=11 Participants
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 Participants
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 Participants
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Colonic Transit at 48 Hours (GC48)
|
4.1 units on a scale
Standard Deviation 0.3
|
4.3 units on a scale
Standard Deviation 0.3
|
3.8 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: after 4 days' treatmentOutcome measures
| Measure |
NaCDC 500 mg
n=11 Participants
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 Participants
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 Participants
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Ascending Colon Emptying (AC t_1/2)
|
9.5 hours
Standard Deviation 2.9
|
8.2 hours
Standard Deviation 1.8
|
15.8 hours
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: after 4 days' treatmentThe subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.
Outcome measures
| Measure |
NaCDC 500 mg
n=11 Participants
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 Participants
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 Participants
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Stool Consistency
|
4.4 units on a scale
Standard Deviation 0.5
|
4.4 units on a scale
Standard Deviation 0.4
|
2.9 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: after 4 days' treatmentPercent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Outcome measures
| Measure |
NaCDC 500 mg
n=11 Participants
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 Participants
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 Participants
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Colonic Filling at 6 Hours
|
52.6 percentage of the radio-labeled meal
Standard Deviation 6.7
|
54.8 percentage of the radio-labeled meal
Standard Deviation 7.1
|
50.6 percentage of the radio-labeled meal
Standard Deviation 6.7
|
Adverse Events
NaCDC 500 mg
NaCDC 1000 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NaCDC 500 mg
n=11 participants at risk
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
|
NaCDC 1000 mg
n=12 participants at risk
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
|
Placebo
n=13 participants at risk；n=12 participants at risk
Participants randomized to this arm received a placebo capsule each day for 4 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Lower abdominal cramping/pain
|
45.5%
5/11 • Number of events 5 • Adverse events were collected during the 4 days of the study.
|
41.7%
5/12 • Number of events 5 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/13 • Adverse events were collected during the 4 days of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/13 • Adverse events were collected during the 4 days of the study.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the 4 days of the study.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/13 • Adverse events were collected during the 4 days of the study.
|
|
General disorders
Headache
|
18.2%
2/11 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
|
Gastrointestinal disorders
Gas
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the 4 days of the study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/13 • Adverse events were collected during the 4 days of the study.
|
|
Gastrointestinal disorders
Heartburn
|
18.2%
2/11 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/12 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/13 • Adverse events were collected during the 4 days of the study.
|
|
General disorders
Light-headedness
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the 4 days of the study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected during the 4 days of the study.
|
0.00%
0/13 • Adverse events were collected during the 4 days of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place