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

• Sponsor: Synthetic Biologics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02495623
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome With Constipation (IBS-C)	Drug: SYN-010 21 mg; Drug: SYN-010 42 mg; Drug: Placebo	Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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 IBS-C
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States

Sponsors and Collaborators

• Synthetic Biologics Inc.

Investigators

• Study Director: Michael Kaleko, M.D., Synthetic Biologics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synthetic Biologics Inc.
• ClinicalTrials.gov Identifier: NCT02495623
• Other Study ID Numbers: SB-2-010-001
• First Posted: Jul 13, 2015
• Last Update Posted: Nov 27, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Irritable Bowel Syndrome; Constipation

Study Results

Participant Flow

Pre-assignment Detail	79 subjects were randomized into the study per IVRS. 63 subjects received at least one dose of SYN-010. 16/79 subjects were not administered a single dose of study drug or placebo. We considered the subject truly randomized once the subject had completed the breath methane test, completed the daily diary entries, and were assigned study drug.

Arm/Group Title	Low Dose	High Dose	Placebo
Arm/Group Description	21 mg SYN-010	42 mg SYN-010	Placebo
Period Title: Overall Study
STARTED	25	26	28
Dosed	22	19	22
COMPLETED	20	17	20
NOT COMPLETED	5	9	8

Baseline Characteristics

Arm/Group Title	Low Dose	High Dose	Placebo	Total
Arm/Group Description	21 mg SYN-010	42 mg SYN-010	Placebo	Total of all reporting groups
Overall Participants	22	19	22	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.6 (6.01)	44.7 (9.54)	46.4 (10.29)	44.6 (8.78)
Sex: Female, Male (Count of Participants)
Female	19 86.4%	14 73.7%	17 77.3%	50 79.4%
Male	3 13.6%	5 26.3%	5 22.7%	13 20.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

79 subjects consented/randomized to treatment. 63 dosed subjects. 59 subjects (21, 20 & 18 for the placebo, 21mg and 42mg, respectively) were included for the analysis of AUC on Day 7, and the subjects with missing CH4 values at either baseline or Day 7 were excluded from the analysis since the area under the curve could not be calculated.

Arm/Group Title	Low Dose	High Dose	Placebo
Arm/Group Description	21 mg SYN-010 SYN-010 21 mg	42 mg SYN-010 SYN-010 42 mg	Placebo Placebo
Measure Participants	20	18	21
Mean (Standard Deviation) [hours*ppm]	99.2 (79.4)	57.3 (43.1)	72.7 (53.5)

Adverse Events

Arm/Group Title	Low Dose		High Dose		Placebo
Arm/Group Description	21 mg SYN-010 SYN-010 21 mg		42 mg SYN-010 SYN-010 42 mg		Placebo Placebo
All Cause Mortality
	Low Dose		High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Low Dose		High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/19 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Low Dose		High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/22 (9.1%)		2/19 (10.5%)		1/22 (4.5%)
Gastrointestinal disorders
Rectal hemorrhage	1/22 (4.5%)	1	0/19 (0%)	0	0/22 (0%)	0
Infections and infestations
Gastroenteritis	0/22 (0%)	0	0/19 (0%)	0	1/22 (4.5%)	1
Investigations
AST increased	0/22 (0%)	0	1/19 (5.3%)	1	0/22 (0%)	0
Blood CPK increased	0/22 (0%)	0	1/19 (5.3%)	1	0/22 (0%)	0
GGT increased	0/22 (0%)	0	1/19 (5.3%)	1	0/22 (0%)	0
Nervous system disorders
Headache	1/22 (4.5%)	1	0/19 (0%)	0	0/22 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.