Clinical Trials

Numerous clinical trials evaluate simethicone across Phase 1 through Phase 4 studies, featuring completed, actively recruiting, terminated, and withdrawn recruitment statuses. Clinical research focuses on gastrointestinal and surgical conditions—including colonoscopy preparation, colonic adenomas, gastric lesions, irritable bowel syndrome, bariatric surgery, and postoperative ileus—to optimize endoscopic visualization and alleviate symptoms. Academic medical centers and healthcare institutions, such as Texas Tech University Health Sciences Center El Paso and Changi General Hospital, serve as major trial sponsors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07674160 NOT_YET_RECRUITING
Quality of Bowel Preparation
Dalin Tzu Chi General Hospital
 2026-08-01
NCT07696793 RECRUITING
Colorectal Cancer Early Detection
Fundacion Clinic per a la Recerca Biomédica
 2026-05-18 PHASE4
NCT06812832 RECRUITING
Simethicone; Bariatric Surgery; Post-operative Pain
Madigan Army Medical Center
 2025-04-08 PHASE4
NCT06919120 NOT_YET_RECRUITING
Colonoscopy
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
 2025-06-01 PHASE4
NCT07501962 NOT_YET_RECRUITING
Colonoscopy
The First Affiliated Hospital of Zhengzhou University
 2026-04-01
NCT07245095 RECRUITING
Esophagogastroduodenoscopy; Simethicone; N-Acetylcysteine; Premedication; Visualization; Esophagogastroduodensocopy (EGD) Procedure; Placebo - Control; Gastritis Associated With Helicobacter Pylori; Tumor Gastric; Lesions in the Esophagus, Stomach, Duodenum or Rectum
Hospital General de Mexicali
 2025-09-12 PHASE2
NCT05100719 NOT_YET_RECRUITING
Irritable Bowel Syndrome; Lactose Intolerance; Lactose Malabsorption
University of Pecs
 2022-09
NCT07293234 NOT_YET_RECRUITING
H Pylori Infection
Asian Institute of Gastroenterology, India
 2026-01
NCT07328880 RECRUITING
Colonoscopy Preparation
Tanta University
 2025-04-01
NCT07461389 COMPLETED
Motility Disorder of Intestine; Mucosal Clarity
CMH Lahore Medical College and Institute of Dentistry
 2025-10-01 PHASE4
NCT06581783 COMPLETED
Endoscopy, Digestive System
Asian Institute of Gastroenterology, India
 2024-12-01
NCT05801055 UNKNOWN
Gastric Disease
Sanjay Gandhi Postgraduate Institute of Medical Sciences
 2023-04-01 PHASE3
NCT03816774 COMPLETED
Colo-rectal Cancer; Colonic Neoplasms
Portuguese Oncology Institute, Coimbra
 2019-06-15
NCT05951712 COMPLETED
Mucosal Erosion
Asian Institute of Gastroenterology, India
 2022-06-16
NCT04709770 UNKNOWN
Chronic Kidney Diseases; Colon Polyp; Dialysis; Complications; Colon Cancer
Alfredo Di Leo
 2021-02-01 PHASE4
NCT05570669 COMPLETED
Colonoscopy
Societa Italiana di Endoscopia Digestiva
 2021-05-25 PHASE4
NCT04802785 UNKNOWN
Air Travel
Dinara Zhumanbayeva
 2021-06 PHASE2; PHASE3
NCT04666324 UNKNOWN
Infantile Colic
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
 2020-12
NCT05175131 COMPLETED
Functional Bowel Disorder
Abbott
 2020-11-27 PHASE3
NCT04368585 COMPLETED
Healthy Volunteers
Spero Therapeutics
 2020-07-01 PHASE1
NCT04487834 COMPLETED
Infantile Colic
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
 2020-04-16 PHASE2
NCT04186936 COMPLETED
Healthy
McNeil AB
 2019-12-05 PHASE1
NCT03490396 TERMINATED
Oral Mucositis
Midatech Pharma US Inc.
 2018-05-15 PHASE4
NCT02334631 COMPLETED
Small Bowel Diseases
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2017-01 PHASE4
NCT03776916 COMPLETED
Gastric Disease
Affiliated Hospital to Academy of Military Medical Sciences
 2019-05-01
NCT03467334 COMPLETED
Infant Colic
Mónica Olivares Martín; PhD
 2017-05-31 PHASE2
NCT04145856 COMPLETED
Irritable Bowel Syndrome
Hospital Juarez de Mexico
 2018-09-03 PHASE4
NCT03119168 COMPLETED
Adenoma Colon
Texas Tech University Health Sciences Center, El Paso
 2017-03-15 PHASE4
NCT03166605 UNKNOWN
Video Capsule Endoscopy
Albany Medical College
 2017-05-03
NCT03429621 COMPLETED
Sterility, Postpartum
Chiang Mai University
 2018-03-08 PHASE3
NCT03410524 COMPLETED
Colonoscopy
University of Nevada, Reno
 2018-01-09 PHASE3
NCT05109390 COMPLETED
Healthy
Alexion Pharmaceuticals, Inc.
 2018-07-27 PHASE1
NCT02604576 COMPLETED
Dyspepsia
EMS
 2017-01-17 PHASE3
NCT02523911 WITHDRAWN
Colorectal Cancer
MercyOne Des Moines Medical Center
 2016-03
NCT03157791 COMPLETED
Colonoscopy; Bowel Preparation
University of Manitoba
 2017-07-05 PHASE4
NCT03146052 COMPLETED
Polyps; Colon Preparation
ASST Rhodense
 2017-03-27
NCT03009604 UNKNOWN
Benign Gynecologic Neoplasm
Assiut University
 2017-01 PHASE3
NCT03119168 Completed
Adenoma Colon
Texas Tech University Health Sciences Center El Paso
 2017-03-15 Phase 4
NCT02846155 UNKNOWN
Stomach Diseases
Changhai Hospital
 2016-05 PHASE2
NCT02540239 COMPLETED
Bowel Preparation Scale; the Amount of Air Bubble; Adenoma Detection Rate
Changhai Hospital
 2015-01
NCT02357303 COMPLETED
Gastric Mucosal Lesion
Portuguese Oncology Institute, Coimbra
 2015-04 PHASE4
NCT02555228 COMPLETED
Lesion of Stomach
Changi General Hospital
 2015-08 PHASE2; PHASE3
NCT02555228 Completed
Lesion of Stomach
Changi General Hospital
 2015-08 Phase 2|Phase 3
NCT02161367 COMPLETED
Postoperative Ileus; Ileus
McMaster University
 2014-10 PHASE4
NCT02984176 COMPLETED
Simethicone
Woman's Health University Hospital, Egypt
 2014-08 PHASE4
NCT02708238 COMPLETED
Infantile Colics
Federico II University
 2014-04 PHASE4
NCT02217982 TERMINATED
Relapsing Remitting Multiple Sclerosis
Rocky Mountain MS Research Group, LLC
 2014-07 PHASE4
NCT02548403 COMPLETED
Colorectal Cancer
Korea University Anam Hospital
 2014-07 PHASE3
NCT01312038 COMPLETED
Otitis Media
University of Pittsburgh
 2011-03 PHASE2
NCT01790139 COMPLETED
Colorectal Neoplasms
Asan Medical Center
 2013-02
NCT01653171 COMPLETED
Stomach Neoplasms
Pontificia Universidad Catolica de Chile
 2012-07 PHASE4
NCT01711437 UNKNOWN
Colonoscopy
Azienda Policlinico Umberto I
 2011-01 PHASE4
NCT01209806 COMPLETED
Bubbles in Colon at Time of Colonoscopy
Thomas Jefferson University
 2009-11
NCT01269671 WITHDRAWN
Functional Abdominal Pain; Irritable Bowel Syndrome; Functional Dyspepsia
Medical College of Wisconsin
 2011-01 PHASE1
NCT00685607 COMPLETED
Diarrhea
Johnson & Johnson Consumer and Personal Products Worldwide
 2008-10 PHASE4
NCT00615303 COMPLETED
Colonoscopy
Ramathibodi Hospital
 2006-12 PHASE4
NCT02340481 COMPLETED
Diarrhea
Xian-Janssen Pharmaceutical Ltd.
 2005-07 PHASE3
NCT00778115 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2004-11

(data from https://clinicaltrials.gov, updated on 2026-06-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Simethicone acts as a nonabsorbable, surface-active agent that reduces the surface tension of gas bubbles in the gastrointestinal tract, causing small bubbles to coalesce into larger free gas masses. By clearing mucosal foam and trapped gas within the lumen, simethicone enhances clear mucosal visualization during diagnostic colonoscopy and relieves symptoms in functional bowel disorders and postoperative ileus.

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>).

Jump to

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