[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472759":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":66,"collaborators":70,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":25,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":25,"enrollmentInfo":86,"targetDuration":25,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Picoprep","ACTIVE_COMPARATOR","Picoprep®:\n\nActive substances: An envelope Picoprep® contains 10 mg sodium picosulfate, 3,5 g magnesium oxide, and 12 g citric acid.\n\nMechanism of action: Sodium picosulfate is a peristaltic agent that increases the peristalsis of the intestine. Magnesium oxide and citric acid are osmotic agents to increase water content in the bowel.\n\nDosage and administration: consist of 2 envelopes, the first envelope, after dissolving in 150 ml water, should be taken 10-18 hours before the colonoscopy, then at least 250mlX5 clear fluid (not only water) over the next hours before the second dose is taken. The second envelope should be taken 4-6 hours before colonoscopy followed by 250mlX3 clear fluid (not only water) over the next hours before colonoscopy. The total fluid intake is approximately 2.3 L.",[13],"Drug: Picoprep",{"label":15,"type":16,"description":17,"interventionNames":18},"Plenvu","EXPERIMENTAL","Plenvu®:\n\nActive substances:\n\nDose nr. 1\n\n1 envelope contains 1 g potassium chloride, 100 g macrogol 3350, 2 g sodium chloride, and 9 g sodium sulfate.\n\nDose nr. 2 1 envelope A contains 1,2 g potassium chloride, 40 g macrogol 3350, and 3,2 g sodium chloride.\n\n1 envelope B contains 7,54 g ascorbic acid (Vit. C) and 48,11 g sodium ascorbate.\n\nMechanism of action: Macrogol 3350 is an osmotic laxative. The added electrolytes are to prevent electrolyte shifting and systemic disturbances.\n\nDosage and administration: two separate nonidentical 500 ml doses are given. 2-day regime: dose nr.1 envelope is dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock evening before colonoscopy day. Dose nr.2 envelope A and B are dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock on the morning of colonoscopy day.\n\nAfter each dose of the dissolved Plenvu®, the patient should drink at least 500ml clear fluid.",[19],"Drug: Plenvu",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","200 patients will be randomised to this arm",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Lars Andersen, Consultant","Region of North Jutland","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Hayder Alqaisi","CONTACT","+4591637005","haidermahmoud1991@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Lars Andersen","+4597661170","L.maagaard@rn.dk",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Aalborg University hospital","RECRUITING","Aalborg","North Jutland","9000","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],9.9187,57.048,{"lat":56,"lon":55},[59,62],{"name":60,"role":36,"phone":61,"phoneExt":25,"email":38},"Hayder Alqaisi, Doctor","004591637005",{"name":63,"role":36,"phone":64,"phoneExt":25,"email":65},"Ole Thorlacius-Ussing, Doctor","004597661126","otu@rn.dk",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Hayder Mahmood Waheeb Alqaisi","Resident doctor",[71,74],{"name":72,"class":73},"Regionshospital Nordjylland","OTHER_GOV",{"name":75,"class":76},"Norgine","INDUSTRY","100472759","phase-4-a-trial-to-compare-efficacy-and-tolerability-of-plenvu-and-picoprep-as-cleansing-agents-before-colonoscopy-100472759",false,"NCT05436054","A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy","A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy","Inclusion Criteria:\n\n* Ambulant colonoscopy\n* Older than18\n\nExclusion Criteria:\n\n* Younger than 18\n* Known with severe heart failure\n* Known with severe renal failure (eGFR\\\u003C30)\n* Known for colonic stenosis\n* Pregnant or breastfeeding\n* Acute colonoscopy\n* Cancer screening program colonoscopy\n* Mentally retarded\n* Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.\n* Patients with Phenylketonuria\n* Patients with Glucose-6-phosphate-dehydrogenase deficiency\n* Patients with colon or rectum resection","ALL","18 Years",{"count":87,"type":88},400,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease.\n\n400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents.\n\nThe effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.",[94],"Colon Disease",[96,97],"colonoscopy","bowel cleansing","2024-11-18",{"date":100,"type":101},"2024-11-19","ACTUAL",{"date":103,"type":101},"2022-10-01",{"date":105,"type":88},"2025-12-01",{"name":5,"class":6},1]