E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gallstone Dissolution |
Disolución cálculos biliares |
|
E.1.1.1 | Medical condition in easily understood language |
Gallstone Dissolution |
Disolución cálculos biliares |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050844 |
E.1.2 | Term | Pancreatitis due to gallstones |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the incidence during follow-up of the composite variable"biliary complication or acute pancreatitis" in patients randomized to receive UDCA or placebo after acute biliary pancreatitis |
Valorar la incidencia durante el seguimiento de la variable compuesta "complicación biliar o pancreatitis aguda" en pacientes aleatorizados a recibir ácido ursodeoxicólico o placebo tras una pancreatitis aguda biliar |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the incidence of complications during follow-up bile (biliary colic, acute cholecystitis, choledocholithiasis de novo and cholangitis acute) and acute pancreatitis.
To evaluate the frequency of total dissolution of gallstones. |
Valorar la incidencia durante el seguimiento de complicaciones biliares (cólico biliar, colecistitis aguda, coledocolitiasis de novo y colangitis aguda) y pancreatitis aguda.
Valorar durante el seguimiento la frecuencia de disolución total de colelitiasis. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients over 18 years. Patients with first episode of acute biliary pancreatitis without previous cholecystectomy
• Diagnosis of acute pancreatitis: at least 2 of these criteria: a) abdominal pain b) or lipasemia amylase greater than 3 times the upper limit of normal c) test image compatible with acute pancreatitis • Diagnosis of biliary etiology: gallstones / microlithiasis / biliary sludge gallbladder diagnosed by ultrasound, CT, MRI or EUS
3. Free to participate in clinical trial, with written informed consent from the patient. 4. Ability to properly complete rating scales
|
Mayores de 18 años. Pacientes con primer episodio de pancreatitis aguda biliar sin colecistectomía previa.
• Diagnóstico de pancreatitis aguda: al menos 2 de estos criterios: a) dolor abdominal b) amilasemia o lipasemia mayor de 3 veces el límite superior de la normalidad c) prueba de imagen compatible con pancreatitis aguda • Diagnóstico de etiología biliar: colelitiasis/microlitiasis/barro biliar vesicular diagnosticado por ecografía, TAC, RMN o ecoendoscopia
3. Aceptación libre de participar en el ensayo, con consentimiento informado por escrito del paciente. 4. Capacidad para cumplimentar adecuadamente las escalas a valorar
|
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E.4 | Principal exclusion criteria |
Ability to perform cholecystectomy within two months. Presence choledocholithiasis. Previous surgical or endoscopic sphincterotomy. Pancreatic cystic lesions not attributable to the very acute gallstone pancreatitis. |
Posibilidad de realizar colecistectomía antes de dos meses. Presencia coledocolitiasis. Esfinterotomía endoscópica o quirúrgica previa. Lesiones quísticas pancreáticas no atribuibles a la propia pancreatitis aguda biliar. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Biliary complication or acute pancreatitis. |
Complicación biliar o pancreatitis aguda. Ocurrencia de algunas de las siguientes variables: cólico biliar, colecistitis aguda, colangitis aguda, coledocolitiasis y/o pancreatitis aguda |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1,2,3,6,9,12 months |
1,2,3,6,9,12 meses |
|
E.5.2 | Secondary end point(s) |
Occurrence of any of the following variables: biliary colic, acute cholecystitis, acute cholangitis, choledocholithiasis and / or acute pancreatitis |
Ocurrencia de algunas de las siguientes variables: cólico biliar, colecistitis aguda, colangitis aguda, coledocolitiasis y/o pancreatitis aguda |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1,2,3,6,9,12 months |
1,2,3,6,9,12 meses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last patient |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |