Clinical Trials

Meloxicam has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4, focusing on managing acute and chronic pain conditions such as osteoarthritis, postoperative incisional discomfort, and localized inflammation. These studies are sponsored by pharmaceutical entities, including Dr. Reddy's Laboratories and Iroko Pharmaceuticals, as well as major medical institutions like Rush University Medical Center and TriHealth Inc. Recruitment statuses range from active recruitment for surgical analgesia evaluations to completed bioavailability and multimodal pain management trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07158476 RECRUITING
ACL Surgery; Pain Management
St. Louis University
 2025-10-21 PHASE4
NCT07430085 NOT_YET_RECRUITING
Periarticular Block; Osteoarthritis (OA); Osteoarthritis (OA) of the Knee; Pain After Surgery; Knee Arthroplasty, Total
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
 2026-07-31 PHASE4
NCT07743684 ACTIVE_NOT_RECRUITING
Temporomandibular Joint Internal Derangement
Hussein Mohammed Ridha
 2026-01-01
NCT07775248 RECRUITING
Osteoarthritis (OA) of the Knee
Henry Ford Health System
 2025-02-11 PHASE4
NCT07200544 RECRUITING
Postoperative Pain, Acute; Skin Cancer
University of Oklahoma
 2025-10-15 PHASE4
NCT05644496 TERMINATED
Post Operative Pain; Osteoarthritis, Knee
Baptist Health South Florida
 2023-03-09 PHASE4
NCT06306131 COMPLETED
Pregnancy Prevention
InnovaGyn, Inc.
 2023-12-10 PHASE2
NCT07462988 COMPLETED
Neck Pain; Mesotherapy
Istanbul Medeniyet University
 2025-01-01
NCT06403046 COMPLETED
Temporomandibular Joint Disc Displacement, With Reduction
Beni-Suef University
 2024-06-01 PHASE1; PHASE2
NCT07549386 COMPLETED
Pain Management; Osteoarthritis
Laboratorios Liomont
 2024-05-24 PHASE3
NCT06704113 NOT_YET_RECRUITING
Dental Pain; Sensation Disorders
Universidad Austral de Chile
 2024-12-15 PHASE4
NCT05672784 RECRUITING
Postoperative Pain
Zagazig University
 2022-11-05
NCT05695352 COMPLETED
Pregnancy Prevention
InnovaGyn, Inc.
 2022-06-28 PHASE2
NCT05550207 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2022-08-31 PHASE3
NCT06904248 COMPLETED
Participants With Acute Moderate to Severe Pain Following Abdominal Surgery
Yangtze River Pharmaceutical Group Co., Ltd.
 2024-01-29 PHASE3
NCT05188053 COMPLETED
Total Knee Arthroplasty
Mayo Clinic
 2022-03-11 PHASE4
NCT05702827 COMPLETED
Stress Urinary Incontinence; Surgical Incision; Pain Vulva
TriHealth Inc.
 2023-01-23 PHASE3
NCT05751421 UNKNOWN
Pain, Postoperative
Rothman Institute Orthopaedics
 2023-02-28 PHASE3
NCT05974501 COMPLETED
Knee Osteoarthritis; Arthroplasty Complications; Postoperative Pain
University of Miami
 2023-09-29 PHASE4
NCT05950152 UNKNOWN
Pain, Post-operative
Beijing Tide Pharmaceutical Co., Ltd
 2023-07 PHASE2
NCT04115098 TERMINATED
Axial Spondyloarthritis
The University of Texas Health Science Center, Houston
 2020-06-25 PHASE2
NCT06902090 COMPLETED
Pain
Yangtze River Pharmaceutical Group Co., Ltd.
 2023-07-05 PHASE1
NCT06379165 COMPLETED
Pain
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2023-05-17 PHASE3
NCT05291598 COMPLETED
Total Knee Replacement; Total Hip Replacement
University of Miami
 2022-05-01 PHASE3
NCT05702827 Recruiting
Stress Urinary Incontinence|Surgical Incision|Pain Vulva
TriHealth Inc.
 2023-01-23 Phase 3
NCT04725357 UNKNOWN
Shoulder Pain
Rothman Institute Orthopaedics
 2021-01-25 PHASE3
NCT05097768 COMPLETED
Symptomatic Irreversible Pulpitis
Alfarabi Colleges
 2021-08-15
NCT04766996 TERMINATED
Anesthesia; Opioid Use
Emory University
 2021-05-17 PHASE4
NCT05181124 COMPLETED
Anti-Ulcer Agents
Onconic Therapeutics Inc.
 2021-03-05 PHASE1
NCT03936192 WITHDRAWN
Knee Osteoarthritis
Eurofarma Laboratorios S.A.
 2019-01 PHASE3
NCT04068051 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2019-07-06 PHASE3
NCT04490434 UNKNOWN
Healthy Male Volunteers
Daewoong Pharmaceutical Co. LTD.
 2020-06-19 PHASE1
NCT04480359 UNKNOWN
Ankylosing Spondylitis
Shanghai University of Traditional Chinese Medicine
 2017-10-01 PHASE2; PHASE3
NCT04322175 UNKNOWN
Healthy Volunteers
Beijing Tongren Hospital
 2019-12-16 PHASE1
NCT04163185 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2019-10-08 PHASE3
NCT04538391 COMPLETED
Cesarean Section Pain
Menoufia University
 2019-03-03
NCT03896009 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2019-03-04 PHASE3
NCT03473665 TERMINATED
Ankylosing Spondylitis; Axial Spondyloarthritis
Columbia University
 2018-03-01 PHASE4
NCT03586934 WITHDRAWN
Shoulder Pain; Opioid Use
Rush University Medical Center
 2018-06-01 PHASE3
NCT02003625 COMPLETED
Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Hematopoietic Stem Cells
Massachusetts General Hospital
 2013-10 PHASE2
NCT04003350 COMPLETED
Osteo Arthritis Knee
Rothman Institute Orthopaedics
 2017-12-21
NCT02078102 COMPLETED
Multiple Myeloma; Non-Hodgkin's Lymphoma
Sherif S. Farag
 2014-03-11 PHASE2
NCT03684265 COMPLETED
Healthy
Boehringer Ingelheim
 2018-10-05 PHASE1
NCT01799213 COMPLETED
Knee Osteoarthritis
VA Office of Research and Development
 2013-09-02 PHASE2
NCT03146000 COMPLETED
Postpartum
Assiut University
 2017-05-01 PHASE3
NCT00731302 COMPLETED
Systemic Lupus Erythematosus
Vanderbilt University
 2005-04 PHASE1
NCT02448199 UNKNOWN
Osteoarthritis
Zodiac Produtos Farmaceuticos S.A.
 2015-07 PHASE3
NCT02255045 COMPLETED
Dysmenorrhea
Laboratorios Andromaco S.A.
 2014-06-27 PHASE2; PHASE3
NCT02405793 WITHDRAWN
Osteoarthritis
Iroko Pharmaceuticals, LLC
 2015-05 PHASE2
NCT02060006 UNKNOWN
Tuberculosis
University of Stellenbosch
 2014-04 PHASE3
NCT02706054 COMPLETED
Low Back Pain
Istituto Ortopedico Rizzoli
 2012-05 PHASE3
NCT01801735 COMPLETED
Osteoarthritis
Iroko Pharmaceuticals, LLC
 2013-03 PHASE3
NCT05125588 COMPLETED
Pharmacokinetics
Joint Stock Company "Farmak"
 2014-01-29 PHASE1
NCT01750931 COMPLETED
Arthritis, Rheumatoid
GlaxoSmithKline
 2013-09-12
NCT01787188 COMPLETED
Osteoarthritis
Iroko Pharmaceuticals, LLC
 2013-02 PHASE3
NCT01839643 COMPLETED
Contraception; Bleeding Pattern
Laboratorios Andromaco S.A.
 2013-01-15 PHASE1
NCT01587508 WITHDRAWN
Acute Lumbago
Eurofarma Laboratorios S.A.
 2013-05 PHASE3
NCT01430559 COMPLETED
Osteoarthritis of the Knee
Pfizer
 2011-10-24
NCT01147289 COMPLETED
Lumbar Sciatic Pain
Eurofarma Laboratorios S.A.
 2011-02 PHASE3
NCT02298218 COMPLETED
Biliary Atresia, Kasai Portoenterostomy Status
Yonsei University
 2009-09 PHASE4
NCT01346137 UNKNOWN
Rupture; Graafian Follicle
Instituto Chileno de Medicina Reproductiva
 2011-01 PHASE2
NCT00152919 COMPLETED
Prostatic Neoplasms
University Health Network, Toronto
 2004-02 PHASE3
NCT00635349 COMPLETED
Osteoarthritis
Janssen Korea, Ltd., Korea
 2007-05 PHASE4
NCT02183181 COMPLETED
Healthy
Boehringer Ingelheim
 2008-11 PHASE1
NCT00618163 COMPLETED
Inflammation
Roxane Laboratories
 2005-03
NCT00601887 COMPLETED
Inflammation
Roxane Laboratories
 2005-03
NCT00239382 COMPLETED
Arthritis, Rheumatoid
Boehringer Ingelheim
 2004-07-01 PHASE3
NCT01161147 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2004-10 PHASE1
NCT00239395 COMPLETED
Osteoarthritis
Boehringer Ingelheim
 2004-07 PHASE3
NCT01161134 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2004-09 PHASE1
NCT00649077 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-08 PHASE1
NCT00649675 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-08 PHASE1
NCT00840879 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2004-02 PHASE1
NCT00840476 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2004-02 PHASE1
NCT00034853 COMPLETED
Arthritis, Juvenile Rheumatoid
Boehringer Ingelheim
 2000-12 PHASE3
NCT00279747 COMPLETED
Arthritis, Juvenile Rheumatoid
Boehringer Ingelheim
 2000-09 PHASE3
NCT02187562 COMPLETED
Healthy
Boehringer Ingelheim
 2002-07 PHASE1
NCT02183168 COMPLETED
Spondylitis, Ankylosing
Boehringer Ingelheim
 2001-07-01 PHASE3
NCT02181309 COMPLETED
Healthy
Boehringer Ingelheim
 2002-01 PHASE1
NCT02229747 COMPLETED
Pharyngitis
Boehringer Ingelheim
 2001-08 PHASE4
NCT02181322 COMPLETED
Healthy
Boehringer Ingelheim
 2001-06 PHASE1
NCT02183064 COMPLETED
Osteoarthritis
Boehringer Ingelheim
 1998-10 PHASE3
NCT02183155 COMPLETED
Healthy
Boehringer Ingelheim
 2000-05 PHASE4
NCT02183129 COMPLETED
Osteoarthritis
Boehringer Ingelheim
 1999-04-01 PHASE4
NCT02276352 COMPLETED
Healthy
Boehringer Ingelheim
 1999-06 PHASE1
NCT02183103 COMPLETED
Healthy
Boehringer Ingelheim
 1999-04 PHASE1
NCT02183025 COMPLETED
Dysmenorrhea
Boehringer Ingelheim
 1998-01 PHASE2
NCT02183116 COMPLETED
Osteoarthritis
Boehringer Ingelheim
 1998-10 PHASE4
NCT02183038 COMPLETED
Pharyngitis
Boehringer Ingelheim
 1998-07 PHASE2
NCT02183090 COMPLETED
Healthy
Boehringer Ingelheim
 1998-11 PHASE1
NCT02183077 COMPLETED
Healthy
Boehringer Ingelheim
 1998-09 PHASE1
NCT02183051 COMPLETED
Pain
Boehringer Ingelheim
 1998-04 PHASE2
NCT00042068 COMPLETED
Arthritis, Rheumatoid
Boehringer Ingelheim
 2002-06 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-10-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Meloxicam selectively binds to and inhibits the cyclooxygenase-2 (COX-2) enzyme, preventing the oxygenation of arachidonic acid into prostaglandin H2. This suppression of prostaglandin biosynthesis reduces proinflammatory signaling, mitigating cellular swelling, pyrexia, and nociceptive sensitization associated with osteoarthritis and acute postoperative pain.

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.