CompletedNCT02495623Updated Nov 27, 2018Results posted

A Study of the Effect of SYN-010 on Subjects With IBS-C

A Phase 2 interventional study of SYN-010 21 mg and SYN-010 42 mg in Irritable Bowel Syndrome With Constipation (IBS-C), sponsored by Theriva Biologics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-27.

Sponsored by Theriva Biologics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 63
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)

Read the detailed description

This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. The entire duration of the study may be up to 43 days (from Screening to the post end-of-study [EOS] visit telephone call).

Conditions studied

Irritable Bowel Syndrome With Constipation (IBS-C)

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects must have IBS-C and have a positive breath CH4 test result (> 10 ppm) at Screening.
Subject must meet the modified Rome III criteria for IBS-C.
Subject must have an average abdominal pain intensity score of ≥ 3 (scale 0-10) reported at Screening and Baseline.
Subject must have an average of fewer than 3 complete spontaneous bowel movement (CSBMs) per week.
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

Exclusion Criteria:

Subject has taken IBS treatments (prescription or over-the-counter), proton pump inhibitors, laxatives, antibiotics.
Subject currently has any structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility, or any unexplained and clinically significant symptoms such as lower GI bleeding, rectal bleeding, heme-positive stool, iron-deficiency anemia, weight loss, or systemic signs of infection.
Subject has been diagnosed with or has a family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score of 6 or 7).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 63 participants (actual)

Study arms

Active comparator
Low Dose
21 mg SYN-010
Drug: SYN-010 21 mg
Active comparator
High Dose
42 mg SYN-010
Drug: SYN-010 42 mg
Placebo comparator
Placebo
Placebo
Drug: Placebo

Interventions

DrugSYN-010 21 mg
DrugSYN-010 42 mg
DrugPlacebo

What researchers measure

Primary outcomes

Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
Time frame: 7 days

Results

Posted Mar 8, 2017

Participant flow

Participant flow — Overall Study
Milestone	Low Dose	High Dose	Placebo
Started	25	26	28
Dosed	22	19	22
Completed	20	17	20
Not completed	5	9	8

Outcome measures

PrimaryChange From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7

Time frame:: 7 days
Reported as:: Mean · hours*ppm

Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
hours*ppm	Low Dose	High Dose	Placebo
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7	99.2 ± 79.4	57.3 ± 43.1	72.7 ± 53.5

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Low Dose	—	0/22 (0%)	2/22 (9.1%)
High Dose	—	0/19 (0%)	2/19 (10.5%)
Placebo	—	0/22 (0%)	1/22 (4.5%)

Most frequent other events

Most frequent other events
Event	Low Dose	High Dose	Placebo
AST increasedInvestigations	0/22	1/19	0/22
Blood CPK increasedInvestigations	0/22	1/19	0/22
GGT increasedInvestigations	0/22	1/19	0/22
Rectal hemorrhageGastrointestinal disorders	1/22	0/19	0/22
GastroenteritisInfections and infestations	0/22	0/19	1/22
HeadacheNervous system disorders	1/22	0/19	0/22

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Low Dose	High Dose	Placebo	Total
Mean	42.6 ± 6.01	44.7 ± 9.54	46.4 ± 10.29	44.6 ± 8.78

Sex: Female, Male
Sex: Female, Male(Participants)	Low Dose	High Dose	Placebo	Total
Female	19	14	17	50
Male	3	5	5	13

Study locations

1 site

Miami, Florida, United States

Registry details

Key details

Study ID: NCT02495623
Lead sponsor: Theriva Biologics, Inc.
Responsible party: Sponsor
First posted: Jul 13, 2015
Start date: Jun 2015
Primary completion: Oct 2015
Completion: Nov 2015
Results posted: Mar 8, 2017
Last update: Nov 27, 2018

Study contacts

Michael Kaleko, M.D.

study director · Synthetic Biologics

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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