Clinical Trials

Numerous clinical trials spanning Phases 1 through 4 evaluate ketoprofen for managing acute and chronic pain, such as musculoskeletal pain, knee osteoarthritis, ankle sprains, and postoperative pain. Sponsored by pharmaceutical organizations and academic institutions, these investigations analyze novel delivery systems, bioequivalence, and opioid-sparing analgesic protocols. Although most recorded studies are completed, others are listed as recruiting, active, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06912763 RECRUITING
Fibrosis Syndrome; Lymphedema; Head &Amp; Neck Cancer; Fibrosis
M.D. Anderson Cancer Center
 2025-08-08 PHASE2
NCT05584046 RECRUITING
Plantar Fasciitis
Chinese University of Hong Kong
 2023-09-20
NCT06731647 RECRUITING
Non-steroidal Anti-inflammatory Drugs; Pleurodesis; Pneumothorax; Pain Management
Centre Hospitalier Universitaire, Amiens
 2025-02-01 PHASE2
NCT06381063 RECRUITING
Acute Postoperative Pain; Non-steroidal Anti-inflammatory Drugs; Cardiac Surgery; Pain Intensity; Multimodal Pain Management
Centre Hospitalier Universitaire, Amiens
 2024-03-27 PHASE3
NCT07319728 ACTIVE_NOT_RECRUITING
Knee Osteoarthritis
New Valley University
 2025-05-10 PHASE1
NCT07610265 COMPLETED
Post Endodontic Pain
Nims University Rajasthan
 2024-04-18 PHASE4
NCT05840406 COMPLETED
Postoperative Pain; Cesarean Section; Wound Heal
University Hospital Sestre Milosrdnice
 2024-09-03
NCT04726592 TERMINATED
Migraine; Migraine Without Aura; Migraine With Aura; Headache
Assistance Publique - Hôpitaux de Paris
 2021-07-08 PHASE3
NCT05062083 TERMINATED
Multiple Sclerosis
National Institute of Mental Health (NIMH)
 2022-06-07 PHASE2
NCT05801172 COMPLETED
Pain; Hysteroscopic Surgery
Jagiellonian University
 2022-07-01
NCT07315698 COMPLETED
Office Hysteroscopy
Indonesia University
 2020-11-01 PHASE4
NCT04622813 COMPLETED
Cholecystectomy; Pain, Postoperative; Opioid Use
American University of Beirut Medical Center
 2021-04-08 PHASE3
NCT04802967 COMPLETED
No Condition
Dompé Farmaceutici S.p.A
 2021-02-08 PHASE1
NCT04500470 COMPLETED
Infertility, Female
Aswan University Hospital
 2020-09-01
NCT04148846 UNKNOWN
Headache, Post-Dural Puncture
University of Sao Paulo General Hospital
 2019-09-20
NCT04421911 COMPLETED
Osteoarthritis
Handok Inc.
 2020-03-20 PHASE3
NCT03025113 COMPLETED
Musculoskeletal Pain
EMS
 2018-03-08 PHASE3
NCT02400047 COMPLETED
Postoperative Nausea and Vomiting
Rennes University Hospital
 2015-06-03 PHASE3
NCT02862977 COMPLETED
Musculoskeletal Pain
EMS
 2017-11-10 PHASE3
NCT03585374 COMPLETED
Acute Traumatic Pain
Mundipharma Pharmaceuticals srl
 2018-02-08 PHASE3
NCT03404908 COMPLETED
Cesarean Section; Postoperative Pain
Medical University of Lublin
 2018-02-07 PHASE4
NCT03244540 COMPLETED
Cesarean Section; Pain, Postoperative; Pain, Neuropathic
Medical University of Lublin
 2017-09-04 PHASE4
NCT04678076 COMPLETED
Healthy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2018-07-23 PHASE1
NCT02804126 COMPLETED
Cesarean Section; Pain Management; Neuropathic Pain
Michał Borys
 2017-06-01 PHASE4
NCT03836807 COMPLETED
Acute Pain
Dompé Farmaceutici S.p.A
 2018-04-04 PHASE3
NCT04678076 Completed
Healthy
Aziende Chimiche Riunite Angelini Francesco S.p.A|Cross Research S.A.
 2018-07-23 Phase 1
NCT01685658 WITHDRAWN
Renal Colic; Acute Renal Colic
Centre Hospitalier Universitaire de Nīmes
 2016-09 PHASE4
NCT03514810 COMPLETED
Major Depressive Disorder
Kufa University
 2017-01-10 PHASE1
NCT02905045 COMPLETED
Pain Relief
Assiut University
 2016-10 PHASE3
NCT02905058 COMPLETED
Pain Relief
Assiut University
 2016-10 PHASE3
NCT02248493 COMPLETED
Pain, Postoperative; Recovery of Function; Child
Lithuanian University of Health Sciences
 2012-11 PHASE4
NCT02730026 COMPLETED
Pain; Other Surgical Procedures
Luis Fernando Simoneti
 2015-06 PHASE4
NCT02257970 COMPLETED
Lymphedema
Stanford University
 2009-03 PHASE4
NCT02439034 COMPLETED
Uterine Cervical Cancer; Upper Aerodigestive Tract Neoplasms
Centre Oscar Lambret
 2015-02 PHASE2
NCT02796547 Withdrawn
Episiotomy
Brugmann University Hospital
 2016-07-14 Phase 2
NCT01882530 TERMINATED
Post Operative Analgesia
Rennes University Hospital
 2013-07-23 PHASE4
NCT02491879 UNKNOWN
Mechanical Low Back Pain
Akdeniz University
 2015-06 PHASE4
NCT02491736 UNKNOWN
Ankle Sprain
Akdeniz University
 2015-06 PHASE4
NCT02619695 UNKNOWN
Low Back Pain
Akdeniz University
 2015-06 PHASE4
NCT01816334 COMPLETED
Sciatica
University Hospital, Grenoble
 2013-01 PHASE4
NCT02180087 UNKNOWN
Cardiac Surgery; Post-operative Pain
University Hospital, Clermont-Ferrand
 2014-02 PHASE2
NCT02393846 COMPLETED
Ankle Sprain
Akdeniz University
 2015-02 PHASE4
NCT02099006 COMPLETED
Female Genital Diseases
University of Rochester
 2013-11 PHASE2; PHASE3
NCT02350296 COMPLETED
Pain Disorders
Dompé Farmaceutici S.p.A
 2014-11-26 PHASE1
NCT02350296 Completed
Pain Disorders
Dompé Farmaceutici S.p.A|Cross Research S.A.
 2014-11-26 Phase 1
NCT02568644 COMPLETED
Migraine
Federal University of Minas Gerais
 2014-07
NCT01890902 WITHDRAWN
Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee
Imprimis Pharmaceuticals, Inc.
 2013-08 PHASE3
NCT02538224 COMPLETED
Chronic Periodontitis
Islamic Azad University, Sanandaj
 2013-07 PHASE2; PHASE3
NCT02638831 COMPLETED
Gonarthrosis; Low Back Pain
Dr. Reddy's Laboratories Limited
 2013-03 PHASE4
NCT00799838 TERMINATED
Pharyngotonsillitis
Sanofi
 2008-11 PHASE4
NCT01566253 COMPLETED
Caesarian Section
University Hospital, Montpellier
 2012-03 PHASE4
NCT02238340 COMPLETED
Surgery
Hospital Central Dr. Luis Ortega
 2012-03 PHASE4
NCT01541059 Completed
Third Molar Extraction
Centre Hospitalier Universitaire de Nīmes
 2012-06 Phase 4
NCT01558622 UNKNOWN
Laparoscopic Nissen Fundoplication
Kavaklıdere Umut Hospital
 2012-03 PHASE4
NCT01228552 UNKNOWN
Migraine Disorders; Migraine Headache; Migraine; Acute Migraine
Behar, Caren, M.D.
 2011-12 PHASE3
NCT01211795 COMPLETED
Migraine
Behar, Caren, M.D.
 2009-10 PHASE3
NCT00927641 COMPLETED
Ankle Sprain
Hisamitsu Pharmaceutical Co., Inc.
 2009-07 PHASE3
NCT00971581 COMPLETED
Pain
Sanofi
 2009-08 PHASE3
NCT00929877 COMPLETED
Pain
Sanofi
 2009-06 PHASE3
NCT00557544 WITHDRAWN
Migraine
IRCCS Burlo Garofolo
 2009-06 PHASE3
NCT00765700 COMPLETED
Sprain; Strain; Acute Soft Tissue Injury
Imprimis Pharmaceuticals, Inc.
 2008-09 PHASE3
NCT00810121 COMPLETED
Pain
Sanofi
 2008-11 PHASE3
NCT00553605 COMPLETED
Pain
Pfizer
 2007-06 PHASE4
NCT00679146 COMPLETED
Low Back Pain
Sanofi
 2008-04 PHASE3
NCT00716547 COMPLETED
Osteoarthritis of the Knee
IDEA AG
 2008-05 PHASE3
NCT00722852 COMPLETED
Osteoarthritis of the Knee
IDEA AG
 2008-06 PHASE3
NCT00680784 COMPLETED
Ankle Sprain
Hisamitsu Pharmaceutical Co., Inc.
 2008-04 PHASE3
NCT00532038 TERMINATED
Osteoarthritis
ZARS Pharma Inc.
 2007-09 PHASE3
NCT00680472 COMPLETED
Pain
Hisamitsu Pharmaceutical Co., Inc.
 2008-04 PHASE3
NCT00488267 COMPLETED
Osteoarthritis
ZARS Pharma Inc.
 2007-06 PHASE3
NCT00792727 COMPLETED
Osteoarthritis of the Knee
Hisamitsu Pharmaceutical Co., Inc.
 2007-09 PHASE3
NCT00426985 TERMINATED
Tendonitis; Bursitis
APR Applied Pharma Research s.a.
 2007-02-07 PHASE3
NCT00745264 COMPLETED
Pharmacokinetic
IDEA AG
 2007-10 PHASE1
NCT00903994 COMPLETED
Tendonitis of the Shoulder, Elbow, or Knee
APR Applied Pharma Research s.a.
 2007-06 PHASE2
NCT00265304 COMPLETED
Osteoarthritis, Knee
IDEA AG
 2005-07 PHASE2
NCT00365586 COMPLETED
Osteoarthritis
APR Applied Pharma Research s.a.
 2006-08 PHASE3
NCT00351104 COMPLETED
Sprain; Strain
APR Applied Pharma Research s.a.
 2006-06 PHASE3
NCT00352625 COMPLETED
Tendonitis; Bursitis
APR Applied Pharma Research s.a.
 2006-06 PHASE3
NCT00108810 COMPLETED
Pain; Osteoarthritis, Knee
ZARS Pharma Inc.
 2005-04 PHASE2
NCT02178293 COMPLETED
Pharyngitis
Boehringer Ingelheim
 1998-09 PHASE4
NCT01223053 WITHDRAWN
Sprain
Imprimis Pharmaceuticals, Inc.
 PHASE3
NCT01020279 COMPLETED
Musculoskeletal Pain
X-pert Med GmbH
 2009-10 PHASE1
NCT00317733 COMPLETED
Osteoarthritis, Knee
IDEA AG
 PHASE2
NCT00188071 COMPLETED
Abortion, Induced
University Hospital, Angers
 2002-09

(data from https://clinicaltrials.gov, updated on 2026-07-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ketoprofen reversibly binds to cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, thereby blocking the downstream conversion of arachidonic acid into pro-inflammatory prostaglandin precursors. This enzymatic inhibition suppresses mediator-driven inflammatory cascades and peripheral nociceptor sensitization, providing significant therapeutic relief for clinical trial conditions such as osteoarthritis, acute musculoskeletal pain, and postoperative discomfort.

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.