Irritable Bowel Syndrome With Constipation (IBS-C)
Conditions
Brief summary
A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients with Irritable Bowel Syndrome with Constipation
Detailed description
This is a Phase 2, multi-center, open-label study. Up to sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. Subjects must have completed the previous SB-2-010-001 study. The entire duration of the study may be up to 57 days (from enrollment to the post end-of-study \[EOS\] visit telephone call).
Interventions
DRUGSYN-010
Sponsors
Theriva Biologics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects from the study SB-2-010-001 (NCT02495623) were given either SYN-010 21 mg, SYN-010 42 mg, or Placebo. The subjects were offered the opportunity to roll over into SB-2-010-002 and receive SYN-010 42 mg. Some of the analyses were done from day one of SYN-010-001.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject has completed Study SB-2-010-001. * Subject must be willing to abstain from or discontinue the use of any laxatives and any prescription and over-the-counter medications or supplements intended to treat constipation from the time of Screening to the end of the study, except as permitted in this protocol. * Subject must agree to refrain from making any lifestyle changes that may affect IBS-C symptoms from the time of Screening to the end of the study.
Exclusion criteria
* Subject has taken IBS treatments (prescription or over-the-counter), proton pump inhibitors, laxatives, antibiotics. * Subject did not complete Study SB-2-010-001 or more than 7 days have elapsed since the subject's last dose of study drug in that study. * Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale \[BSFS\] score of 6 or 7) in the absence of any laxative, or has a BSFS score of 6 for more than 1 spontaneous bowel movement (SBM) or a BSFS score of 7 for any SBM during the last 7 days of diary reporting for Study SB-2-010-001. * Subject has any abnormal laboratory results, electrocardiogram (ECG) findings, or physical examination findings deemed clinically significant by the investigator at the Study SB-2-010-001 End-of-Study Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 56 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 42-mg SYN-010/42-mg SYN-010 42-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study | 17 |
| 21-mg SYN-010/42-mg SYN-010 21-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study | 20 |
| Placebo/42-mg SYN-010 Placebo in study NCT02495623 followed by 42-mg SYN-010 in current study | 17 |
| Total | 54 |
Baseline characteristics
| Characteristic | 42-mg SYN-010/42-mg SYN-010 | 21-mg SYN-010/42-mg SYN-010 | Placebo/42-mg SYN-010 | Total |
|---|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 8.67 | 42.6 years STANDARD_DEVIATION 6.3 | 46.4 years STANDARD_DEVIATION 11.16 | 44.0 years STANDARD_DEVIATION 8.79 |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 13 Participants | 42 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 17 | 2 / 20 | 2 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 | 0 / 17 |
Outcome results
Primary
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.
Time frame: 56 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 42-mg SYN-010/42-mg SYN-010 | 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 |
| 21-mg SYN-010/42-mg SYN-010 | 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. | 63.91 ppm*hr | Standard Deviation 75.68 |
| Placebo/42-mg SYN-010 | 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. | 33.30 ppm*hr | Standard Deviation 34.23 |