- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01834742
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects (OUT)
15 de abril de 2013 actualizado por: Norgine
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects.
In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
161
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Timisoara, Rumania, 300244
- Pierrel Research HP-RO-SRL
-
Timisoara, Rumania
- Pierrel Research HP-RO-SRL
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- The subject's written informed consent must be obtained prior to inclusion.
- Healthy subjects with an age of 18 to 45 years.
- Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in.
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
Exclusion Criteria:
- Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
- Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
- Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
- History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
- Known glucose-6-phosphatase dehydrogenase deficiency.
- Known phenylketonuria.
- History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
- Evidence of dehydration.
- Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
- Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
- Clinically relevant findings on physical examination based on Investigator's judgement.
- Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
- Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
- Subjects who are unwilling to comply with the provisions of the study protocol.
- Concurrent participation in an investigational drug study or participation within 3 month of study entry.
- Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- Previous participation in the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Part A, arm 1
Evening dose 1 plus fixed morning dose
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
Experimental: Part A, arm 2
Evening dose 2 plus fixed morninf does
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
Experimental: Part A, arm 3
Evening dose 3 plus fixed morning dose
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
Comparador activo: Part A, arm 4
Moviprep
|
Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
|
Experimental: Part B, arm 1
Fixed evening dose plus morning dose 1
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
Experimental: Part B, arm 2
Fixed evening dose plus morning dose 2
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
Experimental: Part B, arm 3
Fixed evening dose plus morning dose 3
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
Experimental: Part B, arm 4
Fixed evening dose plus alternative morning dose
|
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Primary Variable
Periodo de tiempo: 36 Hours
|
Stool weight output generated from the start of intake for the following 24 hours.
|
36 Hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PEG3350 concentration
Periodo de tiempo: 96 Hours
|
Concentration of PEG3350 in blood, urine and faeces.
|
96 Hours
|
Sulphate concentration
Periodo de tiempo: 96 hours
|
Concentration of PEG3350 in blood, urine and faeces.
|
96 hours
|
Ascorbic acid concentration
Periodo de tiempo: 96 hours
|
Concentration of ascorbic acid in blood, urine and faeces.
|
96 hours
|
Electrolytes concentration
Periodo de tiempo: 96 hours
|
Concentration of electrolytes in blood, urine and faeces.
|
96 hours
|
Safety profile
Periodo de tiempo: 96 hours
|
Spontaneouly reported adverse events will be recorded throughout the study
|
96 hours
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rodica Cinca, MD, Pierrel Research
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2011
Finalización primaria (Actual)
1 de septiembre de 2011
Finalización del estudio (Actual)
1 de diciembre de 2011
Fechas de registro del estudio
Enviado por primera vez
15 de abril de 2013
Primero enviado que cumplió con los criterios de control de calidad
15 de abril de 2013
Publicado por primera vez (Estimar)
18 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de abril de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
15 de abril de 2013
Última verificación
1 de abril de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NER1006-01/2011 (OUT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer colonrectal
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento
Ensayos clínicos sobre NER1006
-
NorgineTerminadoCáncer colonrectal | Carcinoma colorrectal | Limpieza de colonReino Unido, España, Bélgica, Francia, Alemania, Italia, Polonia
-
NorgineTerminadoCáncer de colon | Carcinoma colorrectal | Limpieza de colonEstados Unidos
-
NorgineTerminado
-
NorgineQuotient SciencesTerminado
-
University of BolognaDesconocido
-
NorgineTerminadoCáncer colonrectal | Carcinoma colorrectal | Limpieza de colonPaíses Bajos, Reino Unido, España, Alemania, Italia, Polonia
-
NorgineXolomon Tree S.L.TerminadoCáncer de colon | Enfermedad del colon | Limpieza de colonEspaña, Portugal