Trial Outcomes & Findings for A Study of the Effect of SYN-010 on Subjects With IBS-C (NCT NCT02495623)
NCT ID: NCT02495623
Last Updated: 2018-11-27
Results Overview
COMPLETED
PHASE2
63 participants
7 days
2018-11-27
Participant Flow
79 subjects were randomized into the study per IVRS. 63 subjects received at least one dose of SYN-010. 16/79 subjects were not administered a single dose of study drug or placebo. We considered the subject truly randomized once the subject had completed the breath methane test, completed the daily diary entries, and were assigned study drug.
Participant milestones
| Measure |
Low Dose
21 mg SYN-010
|
High Dose
42 mg SYN-010
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
28
|
|
Overall Study
Dosed
|
22
|
19
|
22
|
|
Overall Study
COMPLETED
|
20
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effect of SYN-010 on Subjects With IBS-C
Baseline characteristics by cohort
| Measure |
Low Dose
n=22 Participants
21 mg SYN-010
|
High Dose
n=19 Participants
42 mg SYN-010
|
Placebo
n=22 Participants
Placebo
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 6.01 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 9.54 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 8.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 79 subjects consented/randomized to treatment. 63 dosed subjects. 59 subjects (21, 20 \& 18 for the placebo, 21mg and 42mg, respectively) were included for the analysis of AUC on Day 7, and the subjects with missing CH4 values at either baseline or Day 7 were excluded from the analysis since the area under the curve could not be calculated.
Outcome measures
| Measure |
Low Dose
n=20 Participants
21 mg SYN-010
SYN-010 21 mg
|
High Dose
n=18 Participants
42 mg SYN-010
SYN-010 42 mg
|
Placebo
n=21 Participants
Placebo
Placebo
|
|---|---|---|---|
|
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
|
99.2 hours*ppm
Standard Deviation 79.4
|
57.3 hours*ppm
Standard Deviation 43.1
|
72.7 hours*ppm
Standard Deviation 53.5
|
Adverse Events
Low Dose
High Dose
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=22 participants at risk
21 mg SYN-010
SYN-010 21 mg
|
High Dose
n=19 participants at risk
42 mg SYN-010
SYN-010 42 mg
|
Placebo
n=22 participants at risk
Placebo
Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
0.00%
0/22
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/22
|
0.00%
0/19
|
4.5%
1/22 • Number of events 1
|
|
Investigations
AST increased
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
0.00%
0/22
|
|
Investigations
Blood CPK increased
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
0.00%
0/22
|
|
Investigations
GGT increased
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
0.00%
0/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators do not see trial results ahead of public disclosure unless it is under CDA. Investigators will not be allowed to publish or disclose any study results prior to sponsor communicating it to the public.
- Publication restrictions are in place
Restriction type: OTHER