Trial Outcomes & Findings for A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C (NCT NCT02493036)
NCT ID: NCT02493036
Last Updated: 2018-11-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
56 days
Results posted on
2018-11-27
Participant Flow
Participant milestones
| Measure |
High Dose SYN-010
42-mg SYN-010
|
Low Dose SYN-010
21-mg SYN-010
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
17
|
|
Overall Study
COMPLETED
|
16
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C
Baseline characteristics by cohort
| Measure |
42-mg SYN-010/42-mg SYN-010
n=17 Participants
42-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
|
21-mg SYN-010/42-mg SYN-010
n=20 Participants
21-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
|
Placebo/42-mg SYN-010
n=17 Participants
Placebo in study NCT02495623 followed by 42-mg SYN-010 in current study
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 6.30 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 8.79 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 56 daysPopulation: In this table, there are 16, 18 and 14 subjects in the 42mg/42mg, 21mg/42mg and Placebo/42mg group, respectively. This is a change-from-baseline analysis, only subjects with no missing values AT BOTH baseline and Day 56 are included in the analysis, so the number of subjects in each group is less than the number of subjects that started the study.
Outcome measures
| Measure |
42-mg SYN-010/42-mg SYN-010
n=16 Participants
Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
|
21-mg SYN-010/42-mg SYN-010
n=18 Participants
Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
|
Placebo/42-mg SYN-010
n=14 Participants
Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
|
|---|---|---|---|
|
Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose.
|
73.78 ppm*hr
Standard Deviation 70.62
|
63.91 ppm*hr
Standard Deviation 75.68
|
33.30 ppm*hr
Standard Deviation 34.23
|
Adverse Events
42-mg SYN-010/42-mg SYN-010
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
21-mg SYN-010/42-mg SYN-010
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo/42-mg SYN-010
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
42-mg SYN-010/42-mg SYN-010
n=17 participants at risk
Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
|
21-mg SYN-010/42-mg SYN-010
n=20 participants at risk
Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
|
Placebo/42-mg SYN-010
n=17 participants at risk
Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/17
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Investigations
ALT increased
|
0.00%
0/17
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
AST increased
|
0.00%
0/17
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood ALP increased
|
0.00%
0/17
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood CPK increased
|
11.8%
2/17 • Number of events 2
|
0.00%
0/20
|
0.00%
0/17
|
|
Investigations
Blood LDH increased
|
0.00%
0/17
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Investigations
GGT increased
|
0.00%
0/17
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
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