MedPath

Aceclofenac

Generic Name
Aceclofenac
Drug Type
Small Molecule
Chemical Formula
C16H13Cl2NO4
CAS Number
89796-99-6
Unique Ingredient Identifier
RPK779R03H
Background

Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies . Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility . It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation . Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions . In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, Diclofenac, via chemical modification in effort to improve the gastrointestinal tolerability of the drug. It is a more commonly prescribed drug in Europe.

Indication

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Associated Conditions
Ankylosing Spondylitis (AS), Osteoarthritis (OA), Rheumatoid Arthritis

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac

Phase 1
Completed
Conditions
Drug Interaction Potentiation
Interventions
First Posted Date
2022-09-28
Last Posted Date
2023-06-28
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
24
Registration Number
NCT05558150
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting Conditions

Phase 1
Completed
Conditions
Bioequivalence
Interventions
Drug: Airtal® film-coated tablet 100 mg
First Posted Date
2022-04-21
Last Posted Date
2023-06-28
Lead Sponsor
Pharmtechnology LLC
Target Recruit Count
36
Registration Number
NCT05339373
Locations
🇷🇺

X7 Clinical Research, Saint Petersburg, Russian Federation

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole

Phase 1
Completed
Conditions
Drug Interaction Potentiation
Interventions
First Posted Date
2022-02-14
Last Posted Date
2023-06-28
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
72
Registration Number
NCT05237297
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2020-11-23
Last Posted Date
2020-11-23
Lead Sponsor
HK inno.N Corporation
Target Recruit Count
60
Registration Number
NCT04639804
Locations
🇰🇷

Chonbuk National University Hospital, Jeonju, Korea, Republic of

Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2019-10-30
Last Posted Date
2019-10-30
Lead Sponsor
Chung Shan Medical University
Target Recruit Count
40
Registration Number
NCT04144101

Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

Phase 2
Completed
Conditions
Symptomatic Irreversible Pulpitis
Interventions
Other: Placebo
First Posted Date
2017-11-07
Last Posted Date
2017-11-07
Lead Sponsor
Cairo University
Target Recruit Count
70
Registration Number
NCT03335007
Locations
🇪🇬

Cairo University, Cairo, Egypt

Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis

Phase 2
Completed
Conditions
Irreversible Pulpitis
Interventions
Other: Placebo
First Posted Date
2017-05-10
Last Posted Date
2017-11-07
Lead Sponsor
Cairo University
Target Recruit Count
70
Registration Number
NCT03146481
Locations
🇪🇬

Cairo University, Cairo, Egypt

Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers

First Posted Date
2017-04-25
Last Posted Date
2017-04-25
Lead Sponsor
Dong Wha Pharmaceutical Co. Ltd.
Target Recruit Count
30
Registration Number
NCT03127046
Locations
🇰🇷

Chonbuk National University Hospital., Jeonju-si, Jeollabuk-do, Korea, Republic of

Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee

Phase 4
Completed
Conditions
Osteoarthritis of Knee
Interventions
First Posted Date
2016-02-15
Last Posted Date
2016-10-10
Lead Sponsor
Daewon Pharmaceutical Co., Ltd.
Target Recruit Count
191
Registration Number
NCT02682524
Locations
🇰🇷

Inha university hospital, Chung gu, Incheon, Korea, Republic of

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