Clinical study comparing a new signle dose chewable tablet as treatment knee osteoarthritis with moderate to severe pain, compared to Placebo and Celecoxib

• Conditions: Knee osteoarthritis with moderate to severe pain.; MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005398-22-ES
• Lead Sponsor: ARAFARMA GROUP, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-11
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Osteoarthritis of the knee diagnosed by the diagnostic criteria of the ACR.
2. Pain with moderate to severe score between 301 and 400 in the WOMAC subscale pain, or well with a score greater than 4 cm visual analogue scale of 10 cm.
3. Diagnosis clinical pain and functional limitation in the 6 months prior to the inclusion.
4. Male or Felame patients, aged over 40 years.
5. Ability and commitment to compliance with study procedures and
scheduling follow-up visits.
6. Intellectual Ability to understand and sign the Informed Consent document.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 251

Exclusion Criteria

1. Allergy to shellfish or any component of the study medication.
2. Known hypersensitivity to the active substance or any excipients of Celecoxib.
3. Cardiovascular disease incompatible with the use of Celecoxib.
4. Joint or bone disease known as chondrocalcinosis, Paget's disease, arthritis rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis or Wilson's disease.
5. History or presence of active rheumatic disease that could be responsible for a secondary osteoarthritis.
6. Severe swelling of the joint confirmed by physical examination, speed
ESR> 40 mm / h and positive rheumatoid factor.
7. Index of body mass index (BMI) greater than 30 kg/m2.
8. Hematologic or metabolic, liver or kidney abnormalities at the discretion of Investigator, may hinder a patient's serious commitment to adhere to treatment during the study period.
9. Administration intra-articular or systemic corticosteroids in the last 3 months.
10. Previous use of SYSADOAs in the last 6 months.
11. History of significant trauma or surgery on the affected joint.
12. Arthroplasty of the affected joint arthroplasty or programming in the next 6 months.
13. Use of narcotic analgesics.
14. Known hypersensitivity to sulphonamide and paracetamol.
15. Active peptic ulceration or gastrointestinal bleeding.
16. Patients who have experienced asthma, acute rhinitis, nasal polyps, edema urticaria or other allergic-type reactions after taking aspirin
aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs), including
COX-2.
17.Inflammatory Bowel Disease.
18 Estimated creatinine clearance of <30 ml / min
19 Serum albumin <25 g / L
20. Any circumstance which, at the discretion of the investigator, would prevent the patient to follow rigorously the the study protocol.
21. Women of childbearing potential not using a reliable method of birth control.
22. Women who are pregnant or nursing mothers.
23. Patients who are using other investigational agent for the treatment trial.
24. Patients who are in the process of litigation to get the disability or incapacity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified