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

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ClinicalTrials.gov Identifier: NCT02495623
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : March 8, 2017
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions Drug: SYN-010 21 mg
Drug: SYN-010 42 mg
Drug: Placebo
Enrollment 63
Recruitment Details  
Pre-assignment Details 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
Hide 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
Arm/Group Title Low Dose High Dose Placebo Total
Hide Arm/Group Description 21 mg SYN-010 42 mg SYN-010 Placebo Total of all reporting groups
Overall Number of Baseline Participants 22 19 22 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 22 participants 63 participants
42.6  (6.01) 44.7  (9.54) 46.4  (10.29) 44.6  (8.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 22 participants 63 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%
1.Primary Outcome
Title Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:

21 mg SYN-010

SYN-010 21 mg

42 mg SYN-010

SYN-010 42 mg

Placebo

Placebo

Overall Number of Participants Analyzed 20 18 21
Mean (Standard Deviation)
Unit of Measure: hours*ppm
99.2  (79.4) 57.3  (43.1) 72.7  (53.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose High Dose Placebo
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose High Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/19 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose High Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      2/19 (10.53%)      1/22 (4.55%)    
Gastrointestinal disorders       
Rectal hemorrhage  1/22 (4.55%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Infections and infestations       
Gastroenteritis  0/22 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Investigations       
AST increased  0/22 (0.00%)  0 1/19 (5.26%)  1 0/22 (0.00%)  0
Blood CPK increased  0/22 (0.00%)  0 1/19 (5.26%)  1 0/22 (0.00%)  0
GGT increased  0/22 (0.00%)  0 1/19 (5.26%)  1 0/22 (0.00%)  0
Nervous system disorders       
Headache  1/22 (4.55%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Kaleko
Organization: Synthetic Biologics Inc
Phone: (240) 238-3862
EMail: mkaleko@syntheticbiologics.com
Layout table for additonal information
Responsible Party: Synthetic Biologics Inc.
ClinicalTrials.gov Identifier: NCT02495623     History of Changes
Other Study ID Numbers: SB-2-010-001
First Submitted: June 29, 2015
First Posted: July 13, 2015
Results First Submitted: January 18, 2017
Results First Posted: March 8, 2017
Last Update Posted: November 27, 2018