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)
Key facts
- Where
- Ames, Anaheim, Anniston, Atlanta, Aurora, Beavercreek, Boston, Brandon, Charlotte, Chattanooga, Chula Vista, Clearwater, Clinton Township, Colorado Springs, Columbus, Coral Gables, Coronado, Corsicana, Decatur, Doral, Fayetteville, Flint, Garden Grove, Georgetown, Greenville, Guntersville, Harlingen, Harrisburg, Hartsdale, Hazelwood, Hialeah, Homestead, Houma, Houston, Idaho Falls, Jacksonville, Johnson City, Kingsport, Kissimmee, Knoxville, Lancaster, Lawrenceville, Lone Tree, Los Angeles, Lynchburg, Mentor, Meridian, Mesquite, Miami, Miami Beach, Miami Lakes, Miami Springs, Missoula, Missouri City, Mobile, Morton, Murrieta, Nashville, New Port Richey, New Windsor, New York, Norman, North Massapequa, Oak Lawn, Ocala, Ogden, Orlando, Palm Harbor, Pasadena, Pearland, Pembroke Pines, Petersburg, Phoenix, Pittsburgh, Richmond, Richmond Hill, Rochester, Rocky Mount, Salisbury, San Antonio, San Diego, Sandy City, Saraland, Scottsdale, Sherman Oaks, Sunrise, Tampa, Tempe, Tucson, Tulsa, Union City, Uniontown, West Hills, and Winston-Salem, United StatesSee the 94 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07519395, who can take part
Where in United States
- Ames, IowaHospital not named in the registryContact: Jennifer Killion (principal investigator)Taking people
- Anaheim, CaliforniaHospital not named in the registryContact: Amit Bhanvadia (principal investigator)Taking people
- Anniston, AlabamaHospital not named in the registryContact: Pankaj Kashyap (principal investigator)Taking people
- Atlanta, GeorgiaHospital not named in the registryContact: Vasundhara Cheekati (principal investigator)Taking people
- Aurora, ColoradoHospital not named in the registryContact: Timothy Colander (principal investigator)Taking people
- Beavercreek, OhioHospital not named in the registryContact: Daniel Whitmer (principal investigator)Taking people
- Boston, MassachusettsHospital not named in the registryContact: John Leung (principal investigator)Taking people
- Brandon, FloridaHospital not named in the registryContact: GERMAN ALVAREZ (principal investigator)Taking people
- Charlotte, North CarolinaHospital not named in the registryContact: Christopher Dean Ferris (principal investigator)Taking people
- Chattanooga, TennesseeHospital not named in the registryContact: Ramses Vega-Casasnovas (principal investigator)Taking people
- Chula Vista, CaliforniaHospital not named in the registryContact: Erick Alayo (principal investigator)Taking people
- Clearwater, FloridaHospital not named in the registryContact: Michael Weiss (principal investigator)Taking people
- Clinton Township, MichiganHospital not named in the registryContact: Mohanad Suede (principal investigator)Taking people
- Colorado Springs, ColoradoHospital not named in the registryContact: Bhaktasharan Patel (principal investigator)Taking people
- Columbus, OhioHospital not named in the registryContact: Ryan Gaible (principal investigator)Taking people
- Coral Gables, FloridaHospital not named in the registryContact: Jorge Beato (principal investigator)Taking people
- Coronado, CaliforniaHospital not named in the registryContact: Tarek Hassanein (principal investigator)Taking people
- Corsicana, TexasHospital not named in the registryContact: John Updegrove (principal investigator)Taking people
- Decatur, GeorgiaHospital not named in the registryContact: David Rausher (principal investigator)Taking people
- Doral, FloridaHospital not named in the registryContact: Osvaldo Carmona (principal investigator)Taking people
- Fayetteville, ArkansasHospital not named in the registryContact: Nitinchandra Desai (principal investigator)Taking people
- Flint, MichiganHospital not named in the registryContact: Ahmed Arif (principal investigator)Taking people
- Garden Grove, CaliforniaHospital not named in the registryContact: Michael Kurtz (principal investigator)Taking people
- Georgetown, TexasHospital not named in the registryContact: Masi Khaja (principal investigator)Taking people
- Greenville, South CarolinaHospital not named in the registryContact: Phillip Goldstein (principal investigator)Taking people
- Guntersville, AlabamaHospital not named in the registryContact: William A Nixon (principal investigator)Taking people
- Harlingen, TexasHospital not named in the registryContact: Nolan Perez (principal investigator)Taking people
- Harrisburg, PennsylvaniaHospital not named in the registryContact: Adnan Ahmad (principal investigator)Taking people
- Hartsdale, New YorkHospital not named in the registryContact: Michael Gerdis (principal investigator)Taking people
- Hazelwood, MissouriHospital not named in the registryContact: Larry Reed (principal investigator)Taking people
- Hialeah, FloridaHospital not named in the registryContact: Isaac Bassan (principal investigator)Taking people
- Homestead, FloridaHospital not named in the registryContact: Roberto Fernandez (principal investigator)Taking people
- Houma, LouisianaHospital not named in the registryContact: Conar Fitton (principal investigator)Taking people
- Houston, TexasHospital not named in the registryContact: Zeeshan Shaikh (principal investigator)Taking people
- Idaho Falls, IdahoHospital not named in the registryContact: Larry Evans (principal investigator)Taking people
- Jacksonville, FloridaHospital not named in the registryContact: Kristian Sanchack (principal investigator)Taking people
- Johnson City, TennesseeHospital not named in the registryContact: Chakradhar Reddy (principal investigator)Taking people
- Kingsport, TennesseeHospital not named in the registryContact: Stephen Fry (principal investigator)Taking people
- Kissimmee, FloridaHospital not named in the registryContact: Basher Atiquzzaman (principal investigator)Taking people
- Knoxville, TennesseeHospital not named in the registryContact: Amanda Miller (principal investigator)Taking people
- Lancaster, PennsylvaniaHospital not named in the registryContact: Kumaravel Perumalsamy (principal investigator)Taking people
- Lawrenceville, GeorgiaHospital not named in the registryContact: John Lentz III (principal investigator)Taking people
- Lone Tree, ColoradoHospital not named in the registryContact: Carlene Chun (principal investigator)Taking people
- Los Angeles, CaliforniaHospital not named in the registryContact: Myanh Pardee (principal investigator)Taking people
- Lynchburg, VirginiaHospital not named in the registryContact: Larry Clark (principal investigator)Taking people
- Mentor, OhioHospital not named in the registryContact: Keith Friedenberg (principal investigator)Taking people
- Meridian, IdahoHospital not named in the registryContact: David Butuk (principal investigator)Taking people
- Mesquite, TexasHospital not named in the registryContact: Salma Saiger (principal investigator)Taking people
- Miami, FloridaHospital not named in the registryContact: Onix Garib Alpizar (principal investigator)Taking people
- Miami Beach, FloridaHospital not named in the registryContact: Ricardo Mauro Perez Rivera (principal investigator)Taking people
- Miami Lakes, FloridaHospital not named in the registryContact: Lucky Flores (principal investigator)Taking people
- Miami Springs, FloridaHospital not named in the registryContact: Antonio Terrelonge (principal investigator)Taking people
- Missoula, MontanaHospital not named in the registryContact: Clancy Cone (principal investigator)Taking people
- Missouri City, TexasHospital not named in the registryContact: Deirdre Mcmullen (principal investigator)Taking people
- Mobile, AlabamaHospital not named in the registryContact: Jonathan Siegel (principal investigator)Taking people
- Morton, IllinoisHospital not named in the registryContact: Stanley Koch (principal investigator)Taking people
- Murrieta, CaliforniaHospital not named in the registryContact: John Hong (principal investigator)Taking people
- Nashville, TennesseeHospital not named in the registryContact: Stephanie Pointer (principal investigator)Taking people
- New Port Richey, FloridaHospital not named in the registryContact: Curtis Freedland (principal investigator)Taking people
- New Windsor, New YorkHospital not named in the registryContact: Sashi Makam (principal investigator)Taking people
- New YorkHospital not named in the registryContact: Murray Orbuch (principal investigator)Taking people
- Norman, OklahomaHospital not named in the registryContact: Elise Wiesner (principal investigator)Taking people
- North Massapequa, New YorkHospital not named in the registryContact: Michael DiGiovanna (principal investigator)Taking people
- Oak Lawn, IllinoisHospital not named in the registryContact: Charles Berkelhammer (principal investigator)Taking people
- Ocala, FloridaHospital not named in the registryContact: Robert Barish (principal investigator)Taking people
- Ogden, UtahHospital not named in the registryContact: Chad Gonzales (principal investigator)Taking people
- Orlando, FloridaHospital not named in the registryContact: Seela Ramesh (principal investigator)Taking people
- Palm Harbor, FloridaHospital not named in the registryContact: Gary Goldstein (principal investigator)Taking people
- Pasadena, CaliforniaHospital not named in the registryContact: John De Beixedon (principal investigator)Taking people
- Pearland, TexasHospital not named in the registryContact: Jignesh Shah (principal investigator)Taking people
- Pembroke Pines, FloridaHospital not named in the registryContact: Franklin Pimentel (principal investigator)Taking people
- Petersburg, VirginiaHospital not named in the registryContact: Zahid Rashid (principal investigator)Taking people
- Phoenix, ArizonaHospital not named in the registryContact: Reem Haddad (principal investigator)Taking people
- Pittsburgh, PennsylvaniaHospital not named in the registryContact: Shari Rozen (principal investigator)Taking people
- Richmond, VirginiaHospital not named in the registryTaking people
- Richmond Hill, New YorkHospital not named in the registryContact: Gulam Khan (principal investigator)Taking people
- Rochester, MinnesotaHospital not named in the registryContact: Jonathan Goldstein (principal investigator)Taking people
- Rocky Mount, North CarolinaHospital not named in the registryContact: Mark Anderson (principal investigator)Taking people
- Salisbury, North CarolinaHospital not named in the registryContact: Vineet Korrapati (principal investigator)Taking people
- San Antonio, TexasHospital not named in the registryContact: Jeff Bullock (principal investigator)Taking people
- San Diego, CaliforniaHospital not named in the registryContact: Sajiv Chandradas (principal investigator)Taking people
- Sandy City, UtahHospital not named in the registryContact: Robert Barnett (principal investigator)Taking people
- Saraland, AlabamaHospital not named in the registryContact: Howard Rubenstein (principal investigator)Taking people
- Scottsdale, ArizonaHospital not named in the registryContact: Todd Dreitzler (principal investigator)Taking people
- Sherman Oaks, CaliforniaHospital not named in the registryContact: Shahram Jacobs (principal investigator)Taking people
- Sunrise, FloridaHospital not named in the registryContact: Jeffrey Schneider (principal investigator)Taking people
- Tampa, FloridaHospital not named in the registryContact: Sady Alpizar (principal investigator)Taking people
- Tempe, ArizonaHospital not named in the registryContact: Joseph Davis (principal investigator)Taking people
- Tucson, ArizonaHospital not named in the registryContact: Bassel Kisso (principal investigator)Taking people
- Tulsa, OklahomaHospital not named in the registryContact: Harvey Tatum (principal investigator)Taking people
- Union City, GeorgiaHospital not named in the registryContact: Dwight Blake (principal investigator)Taking people
- Uniontown, PennsylvaniaHospital not named in the registryContact: Marc Happe (principal investigator)Taking people
- West Hills, CaliforniaHospital not named in the registryContact: Hessam Aazami (principal investigator)Taking people
- Winston-Salem, North CarolinaHospital not named in the registryContact: Brian Smith (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07519395
- Record updated
- 22 September 2026
- Original description
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.Read full original descriptionShow less
BALANCE - A Two-part, 26-week, Randomized, Double-Blind, Dose-rAnging, pLAcebo-coNtrolled, Phase 2b Study to Evaluate the effiCacy and safEty of Camlipixant in Adults With IBS-D and 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.
Inclusion: 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: 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; 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); 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 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; 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; 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); 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; History or presence of bile salt diarrhea; Positive celiac serology; Elevated fecal calprotectin levels.