- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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 april 2013 bijgewerkt door: 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®.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
161
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Timisoara, Roemenië, 300244
- Pierrel Research HP-RO-SRL
-
Timisoara, Roemenië
- Pierrel Research HP-RO-SRL
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
Experimenteel: 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.
|
Experimenteel: 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.
|
Actieve vergelijker: 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.
|
Experimenteel: 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.
|
Experimenteel: 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.
|
Experimenteel: 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.
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Primary Variable
Tijdsspanne: 36 Hours
|
Stool weight output generated from the start of intake for the following 24 hours.
|
36 Hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
PEG3350 concentration
Tijdsspanne: 96 Hours
|
Concentration of PEG3350 in blood, urine and faeces.
|
96 Hours
|
Sulphate concentration
Tijdsspanne: 96 hours
|
Concentration of PEG3350 in blood, urine and faeces.
|
96 hours
|
Ascorbic acid concentration
Tijdsspanne: 96 hours
|
Concentration of ascorbic acid in blood, urine and faeces.
|
96 hours
|
Electrolytes concentration
Tijdsspanne: 96 hours
|
Concentration of electrolytes in blood, urine and faeces.
|
96 hours
|
Safety profile
Tijdsspanne: 96 hours
|
Spontaneouly reported adverse events will be recorded throughout the study
|
96 hours
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rodica Cinca, MD, Pierrel Research
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2011
Primaire voltooiing (Werkelijk)
1 september 2011
Studie voltooiing (Werkelijk)
1 december 2011
Studieregistratiedata
Eerst ingediend
15 april 2013
Eerst ingediend dat voldeed aan de QC-criteria
15 april 2013
Eerst geplaatst (Schatting)
18 april 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
18 april 2013
Laatste update ingediend die voldeed aan QC-criteria
15 april 2013
Laatst geverifieerd
1 april 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NER1006-01/2011 (OUT)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Colorectale kanker
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op NER1006
-
NorgineVoltooidDarmkanker | Colorectaal carcinoom | Colon ReinigingVerenigde Staten
-
NorgineVoltooidColorectale kanker | Colorectaal carcinoom | Colon ReinigingVerenigd Koninkrijk, Spanje, België, Frankrijk, Duitsland, Italië, Polen
-
NorgineVoltooid
-
NorgineQuotient SciencesVoltooidFarmacokinetischVerenigd Koninkrijk
-
University of BolognaOnbekendZiekte van de dikke darmItalië
-
NorgineVoltooidColorectale kanker | Colorectaal carcinoom | Colon ReinigingNederland, Verenigd Koninkrijk, Spanje, Duitsland, Italië, Polen
-
NorgineXolomon Tree S.L.VoltooidDarmkanker | Ziekte van de dikke darm | Colon ReinigingSpanje, Portugal