Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial
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
Verified date | October 2018 |
Source | Synthetic Biologics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 63 |
Est. completion date | November 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Synthetic Biologics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 | 7 days |
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