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

Theriva Biologics

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Treatments: Drug: SYN-010 21 mg; Drug: SYN-010 42 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02495623

SB-2-010-001

Details and patient eligibility

About

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)

Full 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).

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups, including a placebo group

Low Dose

Active Comparator group

Description:

21 mg SYN-010

Treatment:

Drug: SYN-010 21 mg

High Dose

Active Comparator group

Description:

42 mg SYN-010

Treatment:

Drug: SYN-010 42 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo