docusate

Small moleculeexperimental

Docusate, also known as docusate salts or dioctyl sulfosuccinate, prevents/relieves dry hard stool and thus is used to treat constipation. Results usually occurs 1 to 3 days after the first dose. In North America, docusate and a stimulant laxative such as sennosides are commonly used in bowel treatment protocols associated with institutionalized elderly and oncology treatments. A paucity of evidence is available to support the use of the stool softener docusate yet it continues to be prescribed in everyday clinical practice for the aforementioned populations. While the actual cost of docusate is low, additional costs associated with its administration (i.e. nursing time) and its widespread use can be significant. Docusate is absorbed into the bloodstream and excreted via the gallbladder after undergoing extensive metabolism. The effect of docusate may not necessarily be all due to its surfactant properties. Perfusion studies suggest that docusate inhibits fluid absorption or stimulates secretion in the portion of the small intestine known as the jejunum — NCATS

Clinical trial activity

15 trials · 17 clinical orgs · 0 marketing orgs

Phase 1
1
Phase 2
4
Phase 3
3
Phase 4
5

Earliest trial started Apr 1, 2006 (NCT00902031)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

  • Unspecified targetOTHER

    Surfactant laxative

  • Unspecified targetSurfactant

    surfactant

Chemistry & pharmacology

Loading structure…

SMILES

CCCCC(CC)COC(=O)CC(C(=O)OCC(CC)CCCC)S(=O)(=O)O
Mol. weight
422.58 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • audinorm
  • clear ear
  • colace
  • colace
  • colace
  • correctol stool softener laxative
  • correctol stool softener laxative
  • dialose
  • dialose
  • dioctyl
  • dioctyl
  • dioctyl disodium sulfosuccinate
  • dioctyl disodium sulfosuccinate
  • dioctyl disodium sulfosuccinate
  • dioctyl sodium sulfosuccinate
  • dioctyl sodium sulfosuccinate
  • dioctyl sodium sulfosuccinate
  • dioctyl sulfosuccinate
  • dioctyl sulfosuccinate
  • dioctyl sulfosuccinate
  • dioctyl sulfosuccinic acid
  • docusate
  • docusate
  • docusate
  • docusate
  • docusate
  • docusate
  • docusate
  • docusate calcium
  • docusate salts
  • docusate sodium
  • docusate sodium
  • docusate sodium
  • docusate sodium
  • docusate sodium
  • docusol
  • docusol 100
  • doxinate
  • doxinate
  • d-s-s
  • d-s-s
  • ducosate sodium
  • dulcoease
  • e480
  • e480
  • fletchers' enemette
  • klyx
  • modane soft
  • modane soft
  • molcer
  • molcer
  • molofac
  • molofac
  • norgalax
  • sodium dioctyl sulfosuccinate
  • sodium dioctyl sulfosuccinate
  • soliwax
  • soliwax
  • waxsol
  • waxsol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05423249N/AAug 12, 2022Stony Brook University
NCT04380090Phase 2Feb 20, 2020The Cleveland Clinic
NCT03800745N/ANov 9, 2018The Cleveland Clinic
NCT03342157Phase 2Apr 2, 2018University of Wisconsin
NCT03523715Phase 4Nov 30, 2017University of Southern California
NCT02977286Phase 4Nov 1, 2016Tufts University
NCT02720822Phase 3Aug 1, 2016Flinders University
NCT01773096Phase 4May 1, 2013Shriners Hospitals for Children
NCT01474499Phase 3Sep 1, 2011Ferring
NCT01156129Phase 1Sep 1, 2010University of Nebraska
NCT01044212N/ANov 1, 2009University of Rochester
NCT00571896Phase 2/Phase 3 (Phase 3)Jan 1, 2008University of Connecticut
NCT01879605Phase 4Dec 1, 2007Osaka University, University of Oslo
NCT00799201Phase 4Aug 1, 2007CAMC Health System
NCT00902031N/AApr 1, 2006College of Family Physicians of Canada, Covenant Health, University of Alberta
Showing 15 of 15 trials
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Organizations

Research & Development (17)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
The Cleveland ClinicAcademic/Hospital2222018
CAMC Health SystemAcademic/Hospital1112007
College of Family Physicians of CanadaAcademic/Hospital1012006
Covenant HealthAcademic/Hospital1012006
FerringFor profit1112011
Flinders UniversityAcademic/Hospital1112016
Osaka UniversityAcademic/Hospital1112007
Shriners Hospitals for ChildrenAcademic/Hospital1112013
Stony Brook UniversityAcademic/Hospital1112022
Tufts UniversityAcademic/Hospital1112016
University of AlbertaAcademic/Hospital1112006
University of ConnecticutAcademic/Hospital1112008
University of NebraskaAcademic/Hospital1112010
University of OsloAcademic/Hospital1012007
University of RochesterAcademic/Hospital1112009
University of Southern CaliforniaAcademic/Hospital1112017
University of WisconsinAcademic/Hospital1112018
17 organizations
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