Clinical trial NCT02493036: A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Lead sponsor: Theriva Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hialeah
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Virginia Gardens
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: New York
country: United States
state: New York
Study officials:
References: