- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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 avril 2013 mis à jour par: 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®.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
161
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Timisoara, Roumanie, 300244
- Pierrel Research HP-RO-SRL
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Timisoara, Roumanie
- Pierrel Research HP-RO-SRL
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Part A, arm 1
Evening dose 1 plus fixed morning dose
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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.
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Expérimental: Part A, arm 2
Evening dose 2 plus fixed morninf does
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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.
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Expérimental: Part A, arm 3
Evening dose 3 plus fixed morning dose
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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.
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Comparateur actif: Part A, arm 4
Moviprep
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Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
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Expérimental: Part B, arm 1
Fixed evening dose plus morning dose 1
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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.
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Expérimental: Part B, arm 2
Fixed evening dose plus morning dose 2
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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.
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Expérimental: Part B, arm 3
Fixed evening dose plus morning dose 3
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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.
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Expérimental: Part B, arm 4
Fixed evening dose plus alternative morning dose
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Primary Variable
Délai: 36 Hours
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Stool weight output generated from the start of intake for the following 24 hours.
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36 Hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PEG3350 concentration
Délai: 96 Hours
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Concentration of PEG3350 in blood, urine and faeces.
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96 Hours
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Sulphate concentration
Délai: 96 hours
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Concentration of PEG3350 in blood, urine and faeces.
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96 hours
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Ascorbic acid concentration
Délai: 96 hours
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Concentration of ascorbic acid in blood, urine and faeces.
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96 hours
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Electrolytes concentration
Délai: 96 hours
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Concentration of electrolytes in blood, urine and faeces.
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96 hours
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Safety profile
Délai: 96 hours
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Spontaneouly reported adverse events will be recorded throughout the study
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96 hours
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rodica Cinca, MD, Pierrel Research
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2011
Achèvement primaire (Réel)
1 septembre 2011
Achèvement de l'étude (Réel)
1 décembre 2011
Dates d'inscription aux études
Première soumission
15 avril 2013
Première soumission répondant aux critères de contrôle qualité
15 avril 2013
Première publication (Estimation)
18 avril 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
18 avril 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 avril 2013
Dernière vérification
1 avril 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NER1006-01/2011 (OUT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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