Expired Study
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Miami, Florida


Purpose:

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)


Study summary:

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).


Criteria:

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).


Study is Available At:


Original ID:

SB-2-010-001


NCT ID:

NCT02495623


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Synthetic Biologics Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

63


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Kaleko, M.D.
Study Director
Synthetic Biologics

Study Dates

Start Date:June 2015
Completion Date:November 2015
Completion Type:Actual
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 31, 2018
First Received Date:June 29, 2015
First Results Date:January 18, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
Time Frame:7 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:SYN-010 21 mg
Arm Name:Low Dose
Intervention Type:Drug
Name:SYN-010 42 mg
Arm Name:High Dose
Intervention Type:Drug
Name:Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo
Study Arm Type:Active Comparator
Arm Name:High Dose
Description:42 mg SYN-010
Study Arm Type:Active Comparator
Arm Name:Low Dose
Description:21 mg SYN-010

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Synthetic Biologics Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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