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

April 1, 2025 updated by: Laboratorios Silanes S.A. de C.V.

Efficacy and Safety Study of the Fixed-dose Combination of Celecoxib/Acetaminophen Compared to Celecoxib for the Treatment of Pain in Patients Diagnosed With Osteoarthritis in Acute Exacerbation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Researchers will evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain in patients with osteoarthritis experiencing an acute exacerbation over a 6-week follow-up period. Adverse events related to the study interventions will be recorded throughout the follow-up phase.

Participants will:

Be randomized into one of three intervention groups (A, B, or C).

Attend five scheduled clinic visits (Day 0, and Weeks 1, 2, 4, and 6 of follow-up).

Be permitted to take 500 mg of naproxen as rescue medication, if needed, with prior authorization from the principal investigator.

Study Type

Interventional

Enrollment (Estimated)

231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Recruiting
        • Laboratorio Silanes, S.A. de C.V.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo Suarez-Otero, MD
        • Principal Investigator:
          • Isabel E Rucker-Joerg, MD
        • Principal Investigator:
          • Ivonne A Torres-Quiroz, MD
        • Principal Investigator:
          • Adelfia Urenda-Quezada, MD
        • Principal Investigator:
          • Martha V Chavira-Flores, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Medical conditions affecting prognosis that prevent outpatient management, to be evaluated by the Principal Investigator for subject inclusion relevance.
  • 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.
  • History of chronic liver failure (Child-Pugh A, B, or C).
  • History of acute or severe renal failure (glomerular filtration rate <30 ml/min/1.73 m²), as reported in the medical history.
  • Significant coagulation disorders (e.g., Von Willebrand disease, hemophilia, vitamin K deficiency) or current use of anticoagulants.

Oncologic patients (except basal cell carcinoma) or those with severe illnesses that, according to the investigator, have a poor prognosis or a life expectancy of less than one year, including severe mental illness.

  • Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, dyspnea) and/or contact within the last 14 days with a suspected or confirmed COVID-19 patient.
  • Positive pregnancy test, pregnant women, those currently breastfeeding, or those planning pregnancy during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celecoxib+Acetaminophen
Administered orally, 1 tablet a day during 6 weeks
Drug: Celecoxib + Acetaminohen
One tablet of 200 mg / 200 mg a day
Other Names:
  • Cele + Ace
Experimental: Celecoxib + Acetaminophen
Administered orally, 1 tablet a day during 6 weeks
Drug: Celecoxi + Acetaminophen
One tablet of 200 mg / 500 mg a day
Other Names:
  • Cele + Ace
Active Comparator: Celecoxib
Administered orally, 1 capsule a day during 6 weeks
Drug: Celecoxib
One capsule of 200 mg a day
Other Names:
  • Cele

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 weeks
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.
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a disease-specific questionnaire designed to assess physical function, pain, and stiffness in individuals with hip or knee osteoarthritis, based on their experiences over the past 48 hours. In this study, patients will be assessed by the investigator at Weeks 1, 2, 4, and 6 of follow-up.
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.
Time Frame: 6 weeks
The Visual Analog Scale (VAS) for pain is a straight line where one end represents no pain and the other represents the worst pain imaginable. The investigator will administer the VAS at each visit to assess the patient's pain intensity. At the end of the clinical trial, the percentage change in pain scores will be calculated and compared across treatment groups.
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.
Time Frame: 6 weeks
The Visual Analog Scale (VAS) for pain is a unidimensional measurement instrument consisting of a straight line anchored by descriptors, with one end indicating "no pain" and the other representing "the worst pain imaginable." The investigator will administer the VAS at each study visit to evaluate changes in pain intensity. The proportion of patients achieving a pain reduction of more than 30% from baseline will be documented and compared among treatment groups at Weeks 1, 2, 4, and 6.
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.
Time Frame: 6 weeks
The Short Form-36 (SF-36) is a generic health survey comprising 36 items designed to measure self-reported Health-Related Quality of Life (HRQoL). It evaluates multiple domains of physical and mental health and generates summary scores for both physical and mental components. In this study, the SF-36 questionnaire will be administered to each patient at baseline and again at Week 6 of follow-up.
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To report the treatment adherence rate, expressed as a percentage, for each intervention group.
Time Frame: 6 weeks
Therapeutic adherence will be defined by the principal investigator. Adherence to treatment will be considered adequate if the patient has taken ≥80% of the prescribed doses by the time of the corresponding evaluation.
6 weeks
To describe the proportion of subjects experiencing therapeutic failure during the study, stratified by treatment group.
Time Frame: 6 weeks
Therapeutic failure will be defined by the principal investigator following a medical evaluation. The definition requires the presence of all the following criteria: (1) a change in pain intensity of less than 10 mm on the Visual Analog Scale (VAS), or an increase in VAS score compared to baseline; (2) adherence to treatment of ≥80%; (3) a dosing regimen of every 12 hours (i.e., subjects with dose escalation) maintained for at least 7 days; and (4) absence of comorbidities that could contribute to increased pain, such as new trauma or falls.
6 weeks
To report the proportion of patients requiring dose escalation during the follow-up period, stratified by treatment group.
Time Frame: 6 weeks

At each study visit, dose escalation (one tablet or capsule every 12 hours) may be considered for patients in any of the three treatment arms who meet the following criteria:

A decrease of less than 10 mm, no change, or an increase in pain intensity on the Visual Analog Scale (VAS) compared to the previous visit.

Treatment adherence of ≥80%.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30221-III-23(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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