Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation

NCT06863636 | Recruiting Phase 3 DMC

• 1 other identifier: SIL-30221-III-23(1)
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial designed to evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain associated with acute exacerbations of osteoarthritis.

Conditions

Joint Pain; Knee Osteoarthritis; Hip Osteoarthritis

Keywords

Joint pain; Knee Osteoarthritis; Hip Osteoarthritis; Acute pain

Outcome Measures

Primary Outcomes (2)

• Comparison of the proportion of patients in each treatment group who, based on the baseline assessment, achieved a response according to the OMERACT-OARSI criteria at Weeks 1, 2, 4, and 6 of follow-up.

  OMERACT (Outcome Measures in Rheumatology) and OARSI (Osteoarthritis Research Society International) jointly developed a core outcome set (COS) for clinical trials in hip and knee osteoarthritis. This COS includes four key domains that should be assessed in all trials: pain, physical function, patient global assessment, and- for studies lasting one year or more-joint imaging. In this study, patients will be evaluated by the researcher at follow-up visits occurring at Weeks 1, 2, 4, and 6.

  6 weeks

• Number of participants Number of participants reporting treatment-related adverse events, as recorded in the patient diary.treatment-related adverse events through the patient's diary record.

  To describe the frequency, intensity, and causality of adverse events occurring during the clinical trial, stratified by treatment group. Adverse events will be documented by participants in their patient diaries. Each reported event will be monitored and followed up at the discretion of the investigator.

  6 weeks

Secondary Outcomes (4)

• To analyze the mean change in pain scores, as measured by the WOMAC questionnaire, at Weeks 1, 2, 4, and 6 compared to baseline, by treatment group.

  6 weeks

• To analyze the mean change in pain intensity, as measured by the Visual Analog Scale (VAS), at Weeks 1, 2, 4, and 6 compared to baseline, stratified by treatment group.

  6 weeks

• Comparison of the proportion of subjects in each treatment group who achieve a reduction of ≥30% in pain intensity, as measured by the Visual Analog Scale (VAS), at Weeks 1, 2, 4, and 6 compared to baseline.

  6 weeks

• To analyze the difference in SF-36 quality of life questionnaire scores at six weeks after the initiation of the intervention, compared to baseline, by treatment group.

  6 weeks

Other Outcomes (3)

• To report the treatment adherence rate, expressed as a percentage, for each intervention group.

  6 weeks

• To describe the proportion of subjects experiencing therapeutic failure during the study, stratified by treatment group.

  6 weeks

• To report the proportion of patients requiring dose escalation during the follow-up period, stratified by treatment group.

  6 weeks

Study Arms (3)

Celecoxib+Acetaminophen

EXPERIMENTAL

Administered orally, 1 tablet a day during 6 weeks

Drug: Celecoxib + Acetaminohen

Celecoxib + Acetaminophen

EXPERIMENTAL

Administered orally, 1 tablet a day during 6 weeks

Drug: Celecoxi + Acetaminophen

Celecoxib

ACTIVE COMPARATOR

Administered orally, 1 capsule a day during 6 weeks

Drug: Celecoxib

Interventions

Celecoxib + Acetaminohen DRUG

One tablet of 200 mg / 200 mg a day

Also known as: Cele + Ace

Celecoxib+Acetaminophen

Celecoxi + Acetaminophen DRUG

One tablet of 200 mg / 500 mg a day

Also known as: Cele + Ace

Celecoxib + Acetaminophen

Celecoxib DRUG

One capsule of 200 mg a day

Also known as: Cele

Celecoxib

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agrees to participate in the study and provides written informed consent.
• Prior diagnosis of knee or hip osteoarthritis based on clinical criteria (according to the American College of Rheumatology (ACR) criteria described in Annex 5).
• Pain in the affected joint with exacerbation lasting no more than 3 weeks.
• Patient reports moderate to severe pain intensity (VAS ≥ 40 mm).
• For women of childbearing potential (a woman is considered fertile after menarche and until postmenopause unless permanently sterile), they must agree to use at least ONE of the following contraceptive methods during the study:
• Barrier methods: diaphragm, cervical cap, male condom, female condom, spermicide foam, sponge, or film.
• Hormonal methods: combined oral contraceptives, injectable contraceptives, subdermal implant, contraceptive patch.
• Intrauterine device (IUD): copper or silver IUD, Levonorgestrel intrauterine system (IUS), and/or combinations of the above as deemed acceptable by the physician.
• Women are considered not of childbearing potential if they meet at least ONE of the following criteria:
• Postmenopausal. Premenopausal woman with at least ONE of the following: hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
• Male subjects must agree to use a male condom as a contraceptive method during the study.
• At the discretion of the Principal Investigator (PI) or treating physician, the subject has an indication for treatment with the investigational product and may derive clinical benefit from it.

You may not qualify if:

• Intolerance or allergy to the investigational product or any of its components (as reported in the medical history and patient interview).
• Participation in another clinical study involving an investigational treatment or participation in one within the last two weeks prior to the study start.
• Potential study bias due to employment or relationship with the research center, sponsor, or being part of a vulnerable population.
• History of advanced, severe, progressive, or unstable disease of any kind that may interfere with efficacy and safety assessments or pose a special risk to the patient.
• Medical contraindication to the investigational product.
• History of allergic reaction to NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), Acetaminophen, or known hypersensitivity to any formulation components.
• Significant gastrointestinal disorders, such as gastric ulcers, Crohn's disease, ulcerative colitis, or gastrointestinal bleeding.
• Prior opioid treatment within the last five days, as reported in the medical history.
• History of treatment failure with COX-2 selective inhibitors, as documented in the medical history.
• History of chronic somatic pain unrelated to knee or hip osteoarthritis (e.g., fibromyalgia, metastatic disease, or Paget's disease).
• History of alcohol or drug abuse within the past year.
• Current treatment with NSAIDs, including COX-2 inhibitors, within the last 72 hours before signing informed consent (except for aspirin used for cardioprotective purposes).
• History of arthroscopy, viscosupplementation, or intra-articular steroid use in the last three months.
• Previous surgery on the affected joint within the last six months.
• Major trauma in the affected joint within the last three weeks.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

RECRUITING

Related Publications (6)

• Ebrahimzadeh MH, Makhmalbaf H, Birjandinejad A, Keshtan FG, Hoseini HA, Mazloumi SM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Persian Speaking Patients with Knee Osteoarthritis. Arch Bone Jt Surg. 2014 Mar;2(1):57-62. Epub 2014 Mar 15.

  PMID: 25207315 BACKGROUND

• Puljak L, Marin A, Vrdoljak D, Markotic F, Utrobicic A, Tugwell P. Celecoxib for osteoarthritis. Cochrane Database Syst Rev. 2017 May 22;5(5):CD009865. doi: 10.1002/14651858.CD009865.pub2.

  PMID: 28530031 BACKGROUND

• Krieckaert CL, van Tubergen A, Gehin JE, Hernandez-Breijo B, Le Meledo G, Balsa A, Bohm P, Cucnik S, Elkayam O, Goll GL, Hooijberg F, Jani M, Kiely PD, McCarthy N, Mulleman D, Navarro-Compan V, Payne K, Perry ME, Plasencia-Rodriguez C, Stones SR, Syversen SW, de Vries A, Ward KM, Wolbink G, Isaacs JD. EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2023 Jan;82(1):65-73. doi: 10.1136/annrheumdis-2022-222155. Epub 2022 May 12.

  PMID: 35551063 BACKGROUND

• Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

  PMID: 22563589 BACKGROUND

• Busse JW, Bartlett SJ, Dougados M, Johnston BC, Guyatt GH, Kirwan JR, Kwoh K, Maxwell LJ, Moore A, Singh JA, Stevens R, Strand V, Suarez-Almazor ME, Tugwell P, Wells GA. Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop. J Rheumatol. 2015 Oct;42(10):1962-1970. doi: 10.3899/jrheum.141440. Epub 2015 May 15.

  PMID: 25979719 BACKGROUND

• Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.

  PMID: 31908163 BACKGROUND

MeSH Terms

Conditions

Arthralgia; Osteoarthritis, Knee; Osteoarthritis, Hip; Acute Pain

Interventions

Celecoxib; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases; Acetaminophen; CelE protein, bacteria

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Isabel E Rucker-Joerg, MD

  Clinical Research Institute S.C.

  PRINCIPAL INVESTIGATOR

• Ivonne A Torres-Quiroz, MD

  Unidad de Medicina Especializada SMA

  PRINCIPAL INVESTIGATOR

• Adelfia Urenda-Quezada, MD

  Servicios Avanzados de Investigación Médica Mediadvance, S.C.

  PRINCIPAL INVESTIGATOR

• Martha V Chavira-Flores, MD

  Consultorio Médico "Dr. Rodrigo Suárez Otero"

  PRINCIPAL INVESTIGATOR

• Rodrigo Suarez-Otero, MD

  IMACEN S.A. de C.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge A González, PhD

CONTACT

5254883785; jogonzalez@silanes.com.mx

Yulia Romero-Antonio, B.S.

CONTACT

5254883785; yromero@silanes.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: September 9, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)