Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate polyethylene glycol 400 across diverse applications, including healthy volunteer pharmacokinetic profiles, pediatric and adult functional constipation, dry eye disease, colonoscopy bowel preparation, and radiodermatitis. Sponsored by both major pharmaceutical corporations and academic medical centers, these protocols represent various recruitment statuses, including completed, recruiting, terminated, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06357897 RECRUITING
Functional Constipation
Chulalongkorn University
 2024-05-03
NCT07786363 COMPLETED
Colonoscopy Preparation
Medical University of Warsaw
 2023-06-01
NCT06349031 UNKNOWN
Functional Constipation; Fecal Impaction; Constipation - Functional; Constipation Chronic Idiopathic; Pediatric Functional Constipation
Institute of Medical Sciences and SUM Hospital
 2024-04-15 PHASE4
NCT05660681 COMPLETED
Dry Eye Disease
Calm Water Therapeutics LLC
 2022-12-12
NCT03146052 COMPLETED
Polyps; Colon Preparation
ASST Rhodense
 2017-03-27
NCT02289365 UNKNOWN
Radiodermatitis
Joben Bio-Medical Co., Ltd.
 2014-11 PHASE2
NCT02292459 WITHDRAWN
Constipation
Bayer
 2015-12 PHASE3
NCT01711437 UNKNOWN
Colonoscopy
Azienda Policlinico Umberto I
 2011-01 PHASE4
NCT01330381 COMPLETED
Functional Constipation
Shire
 2011-04-28 PHASE3
NCT00620893 COMPLETED
Dry Eye Syndromes
Bp Consulting, Inc
 2008-02 PHASE4
NCT00627302 COMPLETED
Myopia
Bp Consulting, Inc
 2008-02 PHASE4
NCT00255372 COMPLETED
Chronic Constipation
Ipsen
 2005-04 PHASE3
NCT00622037 COMPLETED
Dry Eye
Bp Consulting, Inc
 2008-02 PHASE4
NCT02182388 COMPLETED
Healthy
Boehringer Ingelheim
 2007-01 PHASE1
NCT02182323 COMPLETED
Healthy
Boehringer Ingelheim
 2006-09 PHASE1
NCT02184338 COMPLETED
Healthy
Boehringer Ingelheim
 2004-08 PHASE1
NCT02182271 TERMINATED
Healthy
Boehringer Ingelheim
 2004-10 PHASE1
NCT02256787 COMPLETED
Healthy
Boehringer Ingelheim
 2004-01 PHASE1
NCT02259894 COMPLETED
Healthy
Boehringer Ingelheim
 2004-03 PHASE1
NCT02253953 COMPLETED
Healthy
Boehringer Ingelheim
 2002-11 PHASE1
NCT02257008 COMPLETED
Healthy
Boehringer Ingelheim
 2003-03 PHASE1
NCT02254538 COMPLETED
Healthy
Boehringer Ingelheim
 2002-05 PHASE1
NCT02254096 COMPLETED
Healthy
Boehringer Ingelheim
 2002-05 PHASE1
NCT02260076 COMPLETED
Healthy
Boehringer Ingelheim
 2001-09 PHASE1
NCT02268760 COMPLETED
Healthy
Boehringer Ingelheim
 2001-06 PHASE1
NCT00276354 COMPLETED
Constipation
Ipsen
 1999-12 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the PEG400 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PEG400 functions as a hydrophilic polymeric co-solvent and surfactant that binds water molecules and enhances the solubility and bioavailability of lipophilic agents. This osmotic and lubricating action promotes luminal fluid retention and epithelial hydration, facilitating gastrointestinal transit and ocular surface moisture in clinical conditions such as functional constipation and dry eye disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.