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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
One tablet of 200 mg / 200 mg a day
One tablet of 200 mg / 500 mg a day
One capsule of 200 mg a day
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
RECRUITINGComparison 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.
Time frame: 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.
Time frame: 6 weeks
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.
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.
Time frame: 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.
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.
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Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 6 weeks