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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)

RecruitingPhase 2Ages 18 Years - 80 YearsAllGlaxoSmithKline
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Antibiotics (e.g., rifaximin, neomycin) * 5-hydroxytryptamine 3 (5-HT3) receptor antagonists (e.g., alosetron, ramosetron, ondansetron) * Mu-opioid receptor agonists (e.g., eluxadoline) * Secretagogues (e.g., linaclotide, lubiprostone, plecanatide, tenapanor) * 5-hydroxytryptamine 4 (5-HT4) receptor agonists (e.g., tegaserod) * Abnormal thyroid function tests less than (\<) Lower limit of normal (LLN) or greater than (\>) upper limit of normal (ULN) confirmed at screening with Thyroid stimulating hormone (TSH) * Positive celiac serology * Elevated fecal calprotectin levels * QT interval corrected using Fridericia's formula (QTcF) \>450 millisecond (msec) or QTcF \>480 msec for participants with bundle branch block using the Fridericia's corrected QT interval (performed during Run-in period considered as screening ECG). * Clinically significant abnormal laboratory tests at screening, after one repeat laboratory test if allowed by the Medical Monitor, including the following: * Alanine aminotransferase (ALT) \>2\*ULN * Total Bilirubin \>1.5\*ULN * Aspartate aminotransferase (AST) \>2\*ULN * Current or chronic history of liver disease (Child-Pugh class A, B, or C) or biliary abnormalities (with the exception of asymptomatic gallstones). Participants with known or suspected Gilbert's Syndrome are not permissible.
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What it tests

  • Placebo
  • Camlipixant
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Where

114 sites
GSK Investigational Site
Anniston, United States
GSK Investigational Site
Guntersville, United States
GSK Investigational Site
Mobile, United States
GSK Investigational Site
Saraland, United States
GSK Investigational Site
Phoenix, United States
GSK Investigational Site
Scottsdale, United States
GSK Investigational Site
Tempe, United States
GSK Investigational Site
Tucson, United States

โ€ฆand 106 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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