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Compares treatment options for Irritable Bowel Syndrome
Official title 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)
ClinicalTrials.gov ID: NCT07519395
What this study is testing
What is Camlipixant?
Camlipixant is an investigational medicine, being studied as a potential treatment for irritable bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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 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
You likely can't join if
- 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...
- 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...
- Prior use of more than two of the following therapies or classes of therapy for the management of IBS:
See the full eligibility 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
- 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...
- 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 (\ ) 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...
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Guntersville, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Scottsdale, Arizona, United States
- Tempe, Arizona, United States
- Anaheim, California, United States
- Chula Vista, California, United States
- Coronado, California, United States
- Garden Grove, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- Pasadena, California, United States
- San Diego, California, United States
- Sherman Oaks, California, United States
- West Hills, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Lone Tree, Colorado, United States
+ 71 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Guntersville, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Scottsdale, Arizona, United States; Tempe, Arizona, United States and 85 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.