RecruitingIrritable Bowel Syndrome

A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)

Eligible age

18–80 yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this study

This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF).
✓ Diagnosis of IBS-D or IBS-M according to the Rome IV V criteria at screening with documented IBS symptoms onset at least 6 months prior to the diagnosis
✓ Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit
✓ Weekly API score \>=4.0 in each week of the run-in period
✓ IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period
✓ IBS-M: an average of at least 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\>)25% of abnormal bowel movements must be Type 6 or 7 and \>25% Type 1 or 2

You may not qualify if…

✕ Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)
✕ History or presence of inflammatory or immune-mediated disorders of the small or large intestine e.g. inflammatory bowel disease, microscopic colitis, or celiac disease
✕ History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening
✕ History or presence of small intestinal bacterial overgrowth within 6 months prior to screening
✕ History or presence of bile salt diarrhea
✕ History of a primary psychiatric diagnosis that the Investigator considers may interfere with study assessments (e.g., schizophrenia, schizoaffective disorder, major depression, anxiety, panic attacks or bipolar disorder) OR Hospital Anxiety and Depression Scale (HADS) score of \>10 on either the anxiety or depression sub-scale at screening.
✕ Prior use of more than two of the following therapies or classes of therapy for the management of IBS:
✕ Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \[TCAs\], Selective serotonin reuptake inhibitor \[SSRIs\], gabapentinoids)