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)
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 criteria at screening
* 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 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 Gastrointestinal (GI) disorders 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 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 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.
* 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.
Primary outcome measure(s)
Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12 — Baseline, Weeks 7 to 12 (time - average) Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Trial sites (110)
Facility
City
Region
Status
GSK Investigational Site
Anniston
Alabama
Recruiting
GSK Investigational Site
Guntersville
Alabama
Recruiting
GSK Investigational Site
Mobile
Alabama
Recruiting
GSK Investigational Site
Saraland
Alabama
Recruiting
GSK Investigational Site
Scottsdale
Arizona
Recruiting
GSK Investigational Site
Tempe
Arizona
Recruiting
GSK Investigational Site
Anaheim
California
Recruiting
GSK Investigational Site
Chula Vista
California
Recruiting
GSK Investigational Site
Coronado
California
Recruiting
GSK Investigational Site
Garden Grove
California
Recruiting
GSK Investigational Site
Lancaster
California
Recruiting
GSK Investigational Site
Lancaster
California
Recruiting
GSK Investigational Site
Los Angeles
California
Recruiting
GSK Investigational Site
Murrieta
California
Recruiting
GSK Investigational Site
Pasadena
California
Recruiting
GSK Investigational Site
San Diego
California
Recruiting
GSK Investigational Site
San Diego
California
Recruiting
GSK Investigational Site
Sherman Oaks
California
Recruiting
GSK Investigational Site
West Hills
California
Recruiting
GSK Investigational Site
Aurora
Colorado
Recruiting
GSK Investigational Site
Colorado Springs
Colorado
Recruiting
GSK Investigational Site
Lone Tree
Colorado
Recruiting
GSK Investigational Site
Brandon
Florida
Recruiting
GSK Investigational Site
Clearwater
Florida
Recruiting
GSK Investigational Site
Coral Gables
Florida
Recruiting
GSK Investigational Site
Doral
Florida
Recruiting
GSK Investigational Site
Hialeah
Florida
Recruiting
GSK Investigational Site
Homestead
Florida
Recruiting
GSK Investigational Site
Jacksonville
Florida
Recruiting
GSK Investigational Site
Kissimmee
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami Beach
Florida
Recruiting
+ 70 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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