Clinical trial • Phase IV • Gastroenterology
URSODEOXYCHOLIC ACID for Recurrent acute biliary pancreatitis
Phase IV trial of URSODEOXYCHOLIC ACID for Recurrent acute biliary pancreatitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Recurrent acute biliary pancreatitis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-11-2024
- First CTIS Authorization Date
- 04-12-2024
Trial design
Randomised, placebo (excipiente número 1 para cápsulas 500 gramos) versus ursobilane 300 mg capsules (ursodeoxycholic acid). ursobilane specified up to 300 mg daily (max daily dose 300 mg); schedule not further specified in available data.-controlled Phase IV trial in Spain.
- Randomised
- Yes
- Comparator
- Placebo (Excipiente número 1 para cápsulas 500 gramos) versus URSOBILANE 300 mg capsules (ursodeoxycholic acid). URSOBILANE specified up to 300 mg daily (max daily dose 300 mg); schedule not further specified in available data.
- Target Sample Size
- 332
- Trial Duration For Participant
- 365
Eligibility
Recruits 332 No vulnerable populations selected. Participants must be adults (18 years or older). Informed consent is required: "Signature of the informed consent." Subject information and informed consent form document available for adults..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable populations selected. Participants must be adults (18 years or older). Informed consent is required: "Signature of the informed consent." Subject information and informed consent form document available for adults.
Inclusion criteria
- {"criterion_text":"- Adulthood (18 years or older)"}
- {"criterion_text":"- Income from PAB (will meet conditions 1 and 2): 1. Diagnosis of acute pancreatitis, at least 2 of the following 3 criteria (2) i) Acute abdominal pain in upper hemiabdomen or mesogastrium ii) Amylasemia or lipasemia greater than 3 times the upper limit of normal iii) Imaging test compatible with acute pancreatitis 2. Diagnosis of biliary etiology: cholelithiasis, microlithiasis or gallbladder sludge diagnosed by ultrasound, CT, MRI or endoscopic ultrasound."}
- {"criterion_text":"- Signature of the informed consent."}
Exclusion criteria
- {"criterion_text":"- Endoscopic cholecystectomy and / or sphincterotomy prior to recruitment"}
- {"criterion_text":"- Hypertriglyceridemia greater than 400 mg / dL during admission or a history of poorly controlled severe hypertriglyceridemia."}
- {"criterion_text":"- Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct of 4 or more mm)"}
- {"criterion_text":"- Pancreatic cystic lesions not attributed to the PAB itself"}
- {"criterion_text":"- Wirsung duct stenosis."}
- {"criterion_text":"- Primary hyperparathyroidism"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)"}
- {"criterion_text":"- Current waiting list at your center for cholecystectomy for PAB less than 30 days"}
- {"criterion_text":"- Randomization more than 3 days after discharge from hospital for PAB"}
- {"criterion_text":"- UDCA consumption in the last 5 years"}
- {"criterion_text":"- Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with gastric or duodenal ulcer, liver or intestinal disorders that interfere with the enterohepatic circulation of bile salts and lactation)."}
- {"criterion_text":"- Presence of choledocholithiasis diagnosed by imaging tests prior to randomization."}
- {"criterion_text":"- Active alcoholism greater than or equal to 5 alcoholic drinks per day or high clinical suspicion of clinically significant alcoholism"}
- {"criterion_text":"- Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Death and / or complication associated with gallstones (new episode of PAB, cholangitis, cholecystitis, choledocholithiasis or biliary colic, variable based on the primary endpoint of the PONCHO clinical trial (1)), until cholecystectomy is performed or until 1 year.","definition_or_measurement_approach":"Incidence of death or biliary complication during follow-up until cholecystectomy is performed or up to one year after initial episode; survival analysis (Kaplan-Meier) described in secondary objectives."}
Recruitment
- Planned Sample Size
- 332
- Recruitment Window Months
- 50
- Consent Approach
- Informed consent required from each participant: "Signature of the informed consent." Subject information and informed consent form available for adults (document titled 'SIS and ICF adults'). Participants are adults (≥18 years). Language(s) of consent form not specified in available materials.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 332
Spain
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 04-12-2024
- Processing Time Days
- 44
- Number Of Sites
- 21
- Number Of Participants
- 332
Sites
- Site Name
- Hospital Costa Del Sol
- Department Name
- Servicio de digestivo
- Contact Person Name
- Robin Rivera Irigoin
- Contact Person Email
- robinri1416@gmail.com
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Servicio de digestivo
- Contact Person Name
- Lourdes Ruíz Rebollo
- Contact Person Email
- mlruizr@saludcastillayleon.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de digestivo
- Contact Person Name
- Claudia Virginia Sánchez Vilar
- Contact Person Email
- claudiasanchez370@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Servicio de digestivo
- Contact Person Name
- Juan Enrique Domínguez Múñoz
- Contact Person Email
- juanenrique.dominguez@usc.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Servicio de digestivo
- Contact Person Name
- Vanesa Bernal Monterde
- Contact Person Email
- informacion.sector2@salud.aragon.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de digestivo
- Contact Person Name
- Ana García García De Paredes
- Contact Person Email
- anaggparedes@gmail.com
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Servicio de digestivo
- Contact Person Name
- María Eugenia Lauret Braña
- Contact Person Email
- meugelb@hotmail.com
- Site Name
- Complejo Hospitalario Universitario De Ourense
- Department Name
- Servicio de digestivo
- Contact Person Name
- Maria Francisco González
- Contact Person Email
- marta.llobet@iisgaliciasur.es
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Servicio de digestivo
- Contact Person Name
- Guillermo García Rayado
- Contact Person Email
- guillermogarcia7@hotmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de digestivo
- Contact Person Name
- Inmaculada Ortíz Polo
- Contact Person Email
- ortizpolo.inmaculada@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Servicio de digestivo
- Contact Person Name
- Laura Patricia Llovet Soto
- Contact Person Email
- laura.llovet@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Servicio de digestivo
- Contact Person Name
- Fernando Casals Seoane
- Contact Person Email
- drcasals@hotmail.com
- Site Name
- Hospital Universitario De Cabueñes
- Department Name
- Servicio de digestivo
- Contact Person Name
- Jose Manuel Olmos Martinez
- Contact Person Email
- c.bec.mar@gmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Servicio de digestivo
- Contact Person Name
- Irene Pascual Sánchez
- Contact Person Email
- irenepascuals@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de digestivo
- Contact Person Name
- Francesc Xavier Molero Richard
- Contact Person Email
- xavier.molero@vhir.org
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de digestivo
- Contact Person Name
- Cristina Carretero Ribón
- Contact Person Email
- ccarretero@unav.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Digestivo
- Contact Person Name
- Silvia Salord Vila
- Contact Person Email
- ssalord@bellvitgehospital.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de digestivo
- Contact Person Name
- Isabel Pascual Moreno
- Contact Person Email
- pascualmorenoisabel@gmail.com
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Servicio de digestivo
- Contact Person Name
- Esther Fort Martorell
- Contact Person Email
- efort.girona.ics@gencat.cat
- Site Name
- Hospital Universitario Donostia
- Department Name
- Servicio de digestivo
- Contact Person Name
- Maria Vaamonde Lorenzo
- Contact Person Email
- MARIA.VAAMONDELORENZO@osakidetza.eus
- Site Name
- Hospital Santa Ana
- Department Name
- Servicio de digestivo
- Contact Person Name
- Antonio M Caballero Mateos
- Contact Person Email
- ogy1492@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Hospital General Universitario Dr. Balmis
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- URSOBILANE 300 mg cápsulas.
- Active Substance
- URSODEOXYCHOLIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Marketing authorisation in Spain (marketingAuthNumber 65.732)
- Starting Dose
- 300 mg
- Dose Levels
- 300 mg daily
- Frequency
- daily
- Maximum Dose
- 300 mg
- Investigational Product Name
- Excipiente número 1 para cápsulas 500 gramos
- Modality
- Other
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