The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Persian Speaking Patients with Knee Osteoarthritis.
Mohammad H Ebrahimzadeh, Hadi Makhmalbaf, Ali Birjandinejad...
https://pubmed.ncbi.nlm.nih.gov/25207315Actively Recruiting
Phase 3
Age: 40Years +
All Genders
ID06863636
Efficacy and Safety Study of Fixed-Dose Combination of Celecoxib and Acetaminophen Compared to Celecoxib Alone for Pain in Osteoarthritis Acute Exacerbation
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2025-04-04
231
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase III, randomized, double-blind clinical trial to compare the effectiveness and safety of a fixed-dose combination of celecoxib and acetaminophen against celecoxib alone for treating pain caused by acute flare-ups of osteoarthritis. The study focuses on patients with osteoarthritis experiencing increased joint pain, aiming to assess pain relief and safety over six weeks. Participants will be randomly assigned to one of three groups receiving either celecoxib plus acetaminophen tablets or celecoxib capsules, all taken orally once daily for six weeks. During the study, participants can take naproxen as a rescue medication if authorized by the principal investigator. The trial includes scheduled visits at the start and during weeks 1, 2, 4, and 6 to monitor progress. Throughout the six-week follow-up, participants will attend five clinic visits for assessments including pain measurement using standardized criteria like OMERACT-OARSI, WOMAC questionnaire, and Visual Analog Scale. Quality of life will also be evaluated. Adverse events will be recorded via patient diaries. The study aims to compare pain response rates and safety between treatments, with careful monitoring of side effects and overall patient wellbeing.
CONDITIONS
Brief Title
Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and provide written informed consent
- Prior diagnosis of knee or hip osteoarthritis based on American College of Rheumatology clinical criteria
- Pain in the affected joint due to acute exacerbation lasting no more than 3 weeks
- Moderate to severe pain intensity with Visual Analog Scale score of 40 mm or higher
- Women of childbearing potential must agree to use at least one accepted contraceptive method during the study
- Men must agree to use a male condom during the study
- Investigator assesses that the subject may benefit from the investigational treatment
You will not qualify if you...
- Allergy or intolerance to the investigational product or its components
- Participation in another clinical study with investigational treatment within the last two weeks
- Conflicts of interest due to employment or relationships with the study center or sponsor
- Medical conditions preventing outpatient management as judged by investigator
- History of severe, progressive, or unstable diseases affecting safety or efficacy assessments
- Medical contraindications to the investigational product
- Allergic reaction history to NSAIDs, acetaminophen, or formulation components
- Significant gastrointestinal disorders like ulcers, Crohn's disease, colitis, or bleeding
- Use of opioids within the last five days
- Previous treatment failure with COX-2 selective inhibitors
- Chronic somatic pain unrelated to osteoarthritis
- History of alcohol or drug abuse within the past year
- Current NSAID use within 72 hours before consent (except low-dose aspirin)
- Joint surgeries or intra-articular treatments within specified recent periods
- Major trauma to affected joint within last three weeks
- History of chronic liver failure or acute/severe renal failure
- Significant coagulation disorders or current anticoagulant use
- Cancer patients (except basal cell carcinoma) or those with poor prognosis or severe mental illness
- Symptoms or recent contact suggesting active COVID-19 infection
- Positive pregnancy test, pregnancy, breastfeeding, or plans for pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants receive one of three oral drug regimens daily for 6 weeks to treat osteoarthritis pain during acute exacerbation.
5 scheduled clinic visits (Day 0, and Weeks 1, 2, 4, and 6)
Follow-up
Duration - 6 weeks
Participants are monitored for safety and adverse events related to the study drugs during the 6-week period after treatment begins.
5 scheduled clinic visits (Day 0, and Weeks 1, 2, 4, and 6)
Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
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Research Team
J
Jorge A González, PhD
Y
Yulia Romero-Antonio, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Charlotte Lm Krieckaert, Astrid van Tubergen, Johanna Elin Gehin...
https://pubmed.ncbi.nlm.nih.gov/35551063American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee.
Marc C Hochberg, Roy D Altman, Karine Toupin April...
https://pubmed.ncbi.nlm.nih.gov/22563589Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop.
Jason W Busse, Susan J Bartlett, Maxime Dougados...
https://pubmed.ncbi.nlm.nih.gov/259797192019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee.
Sharon L Kolasinski, Tuhina Neogi, Marc C Hochberg...
https://pubmed.ncbi.nlm.nih.gov/31908163