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)
A legfontosabb adatok
- Hol
- 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 és Winston-Salem (Egyesült Államok)Mind a 94 helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 80 év között vagy?
Forrás: NCT07519395: ki vehet részt
Helyszínek itt: Egyesült Államok
- Ames, IowaHospital not named in the registryContact: Jennifer Killion (principal investigator)Résztvevőt keres
- Anaheim, CaliforniaHospital not named in the registryContact: Amit Bhanvadia (principal investigator)Résztvevőt keres
- Anniston, AlabamaHospital not named in the registryContact: Pankaj Kashyap (principal investigator)Résztvevőt keres
- Atlanta, GeorgiaHospital not named in the registryContact: Vasundhara Cheekati (principal investigator)Résztvevőt keres
- Aurora, ColoradoHospital not named in the registryContact: Timothy Colander (principal investigator)Résztvevőt keres
- Beavercreek, OhioHospital not named in the registryContact: Daniel Whitmer (principal investigator)Résztvevőt keres
- Boston, MassachusettsHospital not named in the registryContact: John Leung (principal investigator)Résztvevőt keres
- Brandon, FloridaHospital not named in the registryContact: GERMAN ALVAREZ (principal investigator)Résztvevőt keres
- Charlotte, North CarolinaHospital not named in the registryContact: Christopher Dean Ferris (principal investigator)Résztvevőt keres
- Chattanooga, TennesseeHospital not named in the registryContact: Ramses Vega-Casasnovas (principal investigator)Résztvevőt keres
- Chula Vista, CaliforniaHospital not named in the registryContact: Erick Alayo (principal investigator)Résztvevőt keres
- Clearwater, FloridaHospital not named in the registryContact: Michael Weiss (principal investigator)Résztvevőt keres
- Clinton Township, MichiganHospital not named in the registryContact: Mohanad Suede (principal investigator)Résztvevőt keres
- Colorado Springs, ColoradoHospital not named in the registryContact: Bhaktasharan Patel (principal investigator)Résztvevőt keres
- Columbus, OhioHospital not named in the registryContact: Ryan Gaible (principal investigator)Résztvevőt keres
- Coral Gables, FloridaHospital not named in the registryContact: Jorge Beato (principal investigator)Résztvevőt keres
- Coronado, CaliforniaHospital not named in the registryContact: Tarek Hassanein (principal investigator)Résztvevőt keres
- Corsicana, TexasHospital not named in the registryContact: John Updegrove (principal investigator)Résztvevőt keres
- Decatur, GeorgiaHospital not named in the registryContact: David Rausher (principal investigator)Résztvevőt keres
- Doral, FloridaHospital not named in the registryContact: Osvaldo Carmona (principal investigator)Résztvevőt keres
- Fayetteville, ArkansasHospital not named in the registryContact: Nitinchandra Desai (principal investigator)Résztvevőt keres
- Flint, MichiganHospital not named in the registryContact: Ahmed Arif (principal investigator)Résztvevőt keres
- Garden Grove, CaliforniaHospital not named in the registryContact: Michael Kurtz (principal investigator)Résztvevőt keres
- Georgetown, TexasHospital not named in the registryContact: Masi Khaja (principal investigator)Résztvevőt keres
- Greenville, South CarolinaHospital not named in the registryContact: Phillip Goldstein (principal investigator)Résztvevőt keres
- Guntersville, AlabamaHospital not named in the registryContact: William A Nixon (principal investigator)Résztvevőt keres
- Harlingen, TexasHospital not named in the registryContact: Nolan Perez (principal investigator)Résztvevőt keres
- Harrisburg, PennsylvaniaHospital not named in the registryContact: Adnan Ahmad (principal investigator)Résztvevőt keres
- Hartsdale, New YorkHospital not named in the registryContact: Michael Gerdis (principal investigator)Résztvevőt keres
- Hazelwood, MissouriHospital not named in the registryContact: Larry Reed (principal investigator)Résztvevőt keres
- Hialeah, FloridaHospital not named in the registryContact: Isaac Bassan (principal investigator)Résztvevőt keres
- Homestead, FloridaHospital not named in the registryContact: Roberto Fernandez (principal investigator)Résztvevőt keres
- Houma, LouisianaHospital not named in the registryContact: Conar Fitton (principal investigator)Résztvevőt keres
- Houston, TexasHospital not named in the registryContact: Zeeshan Shaikh (principal investigator)Résztvevőt keres
- Idaho Falls, IdahoHospital not named in the registryContact: Larry Evans (principal investigator)Résztvevőt keres
- Jacksonville, FloridaHospital not named in the registryContact: Kristian Sanchack (principal investigator)Résztvevőt keres
- Johnson City, TennesseeHospital not named in the registryContact: Chakradhar Reddy (principal investigator)Résztvevőt keres
- Kingsport, TennesseeHospital not named in the registryContact: Stephen Fry (principal investigator)Résztvevőt keres
- Kissimmee, FloridaHospital not named in the registryContact: Basher Atiquzzaman (principal investigator)Résztvevőt keres
- Knoxville, TennesseeHospital not named in the registryContact: Amanda Miller (principal investigator)Résztvevőt keres
- Lancaster, PennsylvaniaHospital not named in the registryContact: Kumaravel Perumalsamy (principal investigator)Résztvevőt keres
- Lawrenceville, GeorgiaHospital not named in the registryContact: John Lentz III (principal investigator)Résztvevőt keres
- Lone Tree, ColoradoHospital not named in the registryContact: Carlene Chun (principal investigator)Résztvevőt keres
- Los Angeles, CaliforniaHospital not named in the registryContact: Myanh Pardee (principal investigator)Résztvevőt keres
- Lynchburg, VirginiaHospital not named in the registryContact: Larry Clark (principal investigator)Résztvevőt keres
- Mentor, OhioHospital not named in the registryContact: Keith Friedenberg (principal investigator)Résztvevőt keres
- Meridian, IdahoHospital not named in the registryContact: David Butuk (principal investigator)Résztvevőt keres
- Mesquite, TexasHospital not named in the registryContact: Salma Saiger (principal investigator)Résztvevőt keres
- Miami, FloridaHospital not named in the registryContact: Onix Garib Alpizar (principal investigator)Résztvevőt keres
- Miami Beach, FloridaHospital not named in the registryContact: Ricardo Mauro Perez Rivera (principal investigator)Résztvevőt keres
- Miami Lakes, FloridaHospital not named in the registryContact: Lucky Flores (principal investigator)Résztvevőt keres
- Miami Springs, FloridaHospital not named in the registryContact: Antonio Terrelonge (principal investigator)Résztvevőt keres
- Missoula, MontanaHospital not named in the registryContact: Clancy Cone (principal investigator)Résztvevőt keres
- Missouri City, TexasHospital not named in the registryContact: Deirdre Mcmullen (principal investigator)Résztvevőt keres
- Mobile, AlabamaHospital not named in the registryContact: Jonathan Siegel (principal investigator)Résztvevőt keres
- Morton, IllinoisHospital not named in the registryContact: Stanley Koch (principal investigator)Résztvevőt keres
- Murrieta, CaliforniaHospital not named in the registryContact: John Hong (principal investigator)Résztvevőt keres
- Nashville, TennesseeHospital not named in the registryContact: Stephanie Pointer (principal investigator)Résztvevőt keres
- New Port Richey, FloridaHospital not named in the registryContact: Curtis Freedland (principal investigator)Résztvevőt keres
- New Windsor, New YorkHospital not named in the registryContact: Sashi Makam (principal investigator)Résztvevőt keres
- New YorkHospital not named in the registryContact: Murray Orbuch (principal investigator)Résztvevőt keres
- Norman, OklahomaHospital not named in the registryContact: Elise Wiesner (principal investigator)Résztvevőt keres
- North Massapequa, New YorkHospital not named in the registryContact: Michael DiGiovanna (principal investigator)Résztvevőt keres
- Oak Lawn, IllinoisHospital not named in the registryContact: Charles Berkelhammer (principal investigator)Résztvevőt keres
- Ocala, FloridaHospital not named in the registryContact: Robert Barish (principal investigator)Résztvevőt keres
- Ogden, UtahHospital not named in the registryContact: Chad Gonzales (principal investigator)Résztvevőt keres
- Orlando, FloridaHospital not named in the registryContact: Seela Ramesh (principal investigator)Résztvevőt keres
- Palm Harbor, FloridaHospital not named in the registryContact: Gary Goldstein (principal investigator)Résztvevőt keres
- Pasadena, CaliforniaHospital not named in the registryContact: John De Beixedon (principal investigator)Résztvevőt keres
- Pearland, TexasHospital not named in the registryContact: Jignesh Shah (principal investigator)Résztvevőt keres
- Pembroke Pines, FloridaHospital not named in the registryContact: Franklin Pimentel (principal investigator)Résztvevőt keres
- Petersburg, VirginiaHospital not named in the registryContact: Zahid Rashid (principal investigator)Résztvevőt keres
- Phoenix, ArizonaHospital not named in the registryContact: Reem Haddad (principal investigator)Résztvevőt keres
- Pittsburgh, PennsylvaniaHospital not named in the registryContact: Shari Rozen (principal investigator)Résztvevőt keres
- Richmond, VirginiaHospital not named in the registryRésztvevőt keres
- Richmond Hill, New YorkHospital not named in the registryContact: Gulam Khan (principal investigator)Résztvevőt keres
- Rochester, MinnesotaHospital not named in the registryContact: Jonathan Goldstein (principal investigator)Résztvevőt keres
- Rocky Mount, North CarolinaHospital not named in the registryContact: Mark Anderson (principal investigator)Résztvevőt keres
- Salisbury, North CarolinaHospital not named in the registryContact: Vineet Korrapati (principal investigator)Résztvevőt keres
- San Antonio, TexasHospital not named in the registryContact: Jeff Bullock (principal investigator)Résztvevőt keres
- San Diego, CaliforniaHospital not named in the registryContact: Sajiv Chandradas (principal investigator)Résztvevőt keres
- Sandy City, UtahHospital not named in the registryContact: Robert Barnett (principal investigator)Résztvevőt keres
- Saraland, AlabamaHospital not named in the registryContact: Howard Rubenstein (principal investigator)Résztvevőt keres
- Scottsdale, ArizonaHospital not named in the registryContact: Todd Dreitzler (principal investigator)Résztvevőt keres
- Sherman Oaks, CaliforniaHospital not named in the registryContact: Shahram Jacobs (principal investigator)Résztvevőt keres
- Sunrise, FloridaHospital not named in the registryContact: Jeffrey Schneider (principal investigator)Résztvevőt keres
- Tampa, FloridaHospital not named in the registryContact: Sady Alpizar (principal investigator)Résztvevőt keres
- Tempe, ArizonaHospital not named in the registryContact: Joseph Davis (principal investigator)Résztvevőt keres
- Tucson, ArizonaHospital not named in the registryContact: Bassel Kisso (principal investigator)Résztvevőt keres
- Tulsa, OklahomaHospital not named in the registryContact: Harvey Tatum (principal investigator)Résztvevőt keres
- Union City, GeorgiaHospital not named in the registryContact: Dwight Blake (principal investigator)Résztvevőt keres
- Uniontown, PennsylvaniaHospital not named in the registryContact: Marc Happe (principal investigator)Résztvevőt keres
- West Hills, CaliforniaHospital not named in the registryContact: Hessam Aazami (principal investigator)Résztvevőt keres
- Winston-Salem, North CarolinaHospital not named in the registryContact: Brian Smith (principal investigator)Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- GlaxoSmithKline
- Azonosító
- NCT07519395
- A regiszteradat frissítve
- 2026. szeptember 22.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.