Drugs / Sodium Picosulfate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) PREPOPIK 2012-07-16 fda.gov

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07700277 Aug 2026 → Aug 2027 expected intestinal disorder Ottawa Hospital Research Institute Not yet recruiting No outcome recorded
Phase 11 trial
Phase 1 NCT02211911 Feb → May 2008 Boehringer Ingelheim Completed No outcome recorded
Phase 21 trial
Phase 2 NCT02979223 Nov 2016 → Jun 2017 National Cancer Center, Korea Completed No outcome recorded
Phase 35 trials
Phase 3 NCT05726097 Feb → Oct 2023 colorectal cancer, inflammatory bowel disease, polyp of colon Region Skane Completed No outcome recorded
Phase 3 NCT01984008 Oct 2013 → Mar 2014 Universal Integrated Corp. Completed No outcome recorded
Phase 3 NCT01655095 Jul → Oct 2012 polyp Queen's University Completed No outcome recorded
Phase 3 NCT01065857 Jan → Jun 2010 Laboratorios Casen-Fleet S.L.U. Completed No outcome recorded
Phase 3 NCT00576810 Oct 2007 → Jan 2009 constipation disorder Boehringer Ingelheim Completed No outcome recorded
Phase 49 trials
Phase 4 NCT07696793 May 2026 → May 2028 expected colorectal cancer Fundacion Clinic per a la Recerca Biomédica Recruiting No outcome recorded
Phase 4 NCT04161599 Mar 2022 → Jun 2024 Hospital Universitari Vall d'Hebron Research Institute Unknown No outcome recorded
Phase 4 NCT02070341 Feb → Jul 2014 Queen's University Terminated No outcome recorded
Phase 4 NCT01627171 Sep 2012 → Dec 2013 St. Joseph's Healthcare Hamilton Unknown No outcome recorded
Phase 4 NCT01481714 Nov 2011 → Mar 2012 Infante, Javier Molina, M.D. Unknown No outcome recorded
Phase 4 NCT01603654 Jan → Jun 2011 ASST Fatebenefratelli Sacco Completed No outcome recorded
Phase 4 NCT00885274 Nov 2008 → Mar 2011 Queen's University Completed No outcome recorded
Phase 4 NCT00885430 Jul 2008 Queen's University Completed No outcome recorded
Phase 4 NCT00380497 Sep 2006 → Sep 2007 colonic duplication The Hospital for Sick Children Completed No outcome recorded
Phase not applicable2 trials
NCT04033250 Sep 2019 → Sep 2020 Rambam Health Care Campus Unknown No outcome recorded
NCT01093274 Rabin Medical Center Unknown No outcome recorded
Also used as a comparator or background therapy in 16 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT04593446 Comparator Nov 2020 → Dec 2021 colorectal cancer National Cancer Center, Korea Unknown No outcome recorded
Phase 36 trials
Phase 3 NCT07218523 Comparator Dec 2025 → Jan 2027 expected Norgine Recruiting No outcome recorded
Phase 3 NCT05144295 Comparator Jan → Aug 2022 Alexandria University Completed No outcome recorded
Phase 3 NCT04767633 Comparator Apr 2021 → Apr 2022 intestinal disorder Azienda Ospedaliera "Sant'Andrea" Unknown No outcome recorded
Phase 3 NCT02273141 Comparator Nov 2014 → Aug 2015 colorectal carcinoma Norgine Completed No outcome recorded
Phase 3 NCT03074448 Comparator May → Sep 2014 Kaiser Clinic and Hospital Completed No outcome recorded
Phase 48 trials
Phase 4 NCT06339697 Comparator Dec 2022 → Jun 2023 polyp of colon Zhang Yanli Completed No outcome recorded
Phase 4 NCT05148494 Comparator Mar 2022 → Aug 2026 overdue colorectal neoplasm Nova Scotia Health Authority Recruiting No outcome recorded
Phase 4 NCT02024022 Comparator Feb 2014 → Sep 2015 Clinical Hospital Colentina Completed No outcome recorded
Phase 4 NCT01554111 Comparator Mar 2012 → Sep 2015 colonic disorder Queen's University Completed No outcome recorded
Phase 4 NCT01649674 Comparator Nov 2011 → Dec 2024 National Cancer Institute, Naples Unknown No outcome recorded
Phase not applicable1 trial
NCT01596686 Comparator May → Dec 2012 Clinical Hospital Colentina Completed No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 35 sources stand behind the page.

FieldValueCited text
Known as Sodium Picosulfate “A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops...” NCT00576810
12

Sodium Picosulfate and Magnesium Salt (SP+MS) Solution” NCT02273141

“compound sodium picosulfateNCT06339697

NCT04593446

NCT07700277

NCT07218523

NCT05144295

NCT03074448

NCT02211911

NCT04033250

NCT04767633

NCT02979223

NCT04161599

Known as Citrafleet ClinicalTrials.gov intervention name — accepted as the source's own label NCT07696793
Known as Dulcolax “A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops...” NCT00576810
Known as Laxoberal “A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops...” NCT00576810
Known as magnesiumoxid + sodium picosulfate ClinicalTrials.gov intervention name — accepted as the source's own label NCT05726097
Known as Pico Salax “Patient is to take Pico Salax oral bowel preparation which is a combination product consisting of 10 mg picosulfate sodium, 3.5 g magnesium oxide, and 12 g citric acid per...” NCT05148494
9

NCT00410215

NCT00885274

NCT00380497

NCT01415687

NCT00885430

NCT05148494

NCT02070341

NCT00677794

NCT01655095

Known as picolax ClinicalTrials.gov intervention name — accepted as the source's own label NCT00460837
Known as Picoprep “Sodium Picosulfate solution (Picoprep)” NCT03074448
Known as PicosolutionⓇ “Sodium Picosulfate Solution(PicosolutionⓇ)” NCT04593446
Known as Picosulfate sodium ClinicalTrials.gov intervention name — accepted as the source's own label NCT01627171
2

NCT01984008

NCT01554111

Known as PMC “sodium picosulphate/magnesium citrate (PMC)” NCT01603654
Known as sodium picosulphate “comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol (PEG)” PMID 23799210 Jun 2013
6

“bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate” NCT02024022

NCT01093274

NCT00576810

NCT01649674

NCT01065857

NCT01481714

Known as sodium picosulphate/magnesium citrate sodium picosulphate/magnesium citrate (PMC)” NCT01603654
1

NCT01603654

Route Oral “two sachets of picosalax taken orally the day prior to colonoscopy” NCT00410215