Irritable Bowel Syndrome study: Camlipixant
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 oral medication being studied for the treatment of irritable bowel syndrome with diarrhea (IBS‑D) and mixed IBS (IBS‑M).
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
- The study will see if camlipixant helps people with IBS-D or IBS-M and if it is safe to use.
- Who it's for
- Adults who have irritable bowel syndrome with diarrhea or mixed symptoms.
- What's involved
- Participants will receive either camlipixant or a placebo, then some will be re‑randomized to a higher dose or stop the drug after the first part of the study.
- Time commitment
- The study lasts two parts; participants will have visits and tests as directed by the study schedule.
- 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 V criteria at screening with documented IBS symptoms onset at least 6 months prior to the...
- 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 disorders of the small or large intestine e.g.
- 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...
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 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...
- 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...
- 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 (performed during Run-in period...
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Anniston, Alabama, United States
- Guntersville, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tempe, Arizona, United States
- Tucson, 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
+ 74 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, but 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?
This study is enrolling now at Anniston, Alabama, United States; Guntersville, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States and 88 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.