RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF THE EFFICACY, TOLERABILITY AND SAFETY OF VALDECOXIB (BEXTRA®)10 MG OD VS. DICLOFENAC SODIUM 50 MG TDS FOR 6 WEEKS IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. - N/A

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2004-001713-34-GB
• Date of registration: 17/02/2005
• Prospective Registration: No
• Primary sponsor: Pfizer Limited
• Public title: RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF THE EFFICACY, TOLERABILITY AND SAFETY OF VALDECOXIB (BEXTRA®)10 MG OD VS. DICLOFENAC SODIUM 50 MG TDS FOR 6 WEEKS IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. - N/A
• Scientific title: RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF THE EFFICACY, TOLERABILITY AND SAFETY OF VALDECOXIB (BEXTRA®)10 MG OD VS. DICLOFENAC SODIUM 50 MG TDS FOR 6 WEEKS IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. - N/A
• Date of first enrolment: 11/01/2005
• Target sample size: 516
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001713-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other:

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. The subject must be 55 years of age or older.
2. If the subject is a female and of childbearing potential, including females who are less then two years postmenopausal, she has been using adequate contraception since her last menses and will use adequate contraception including abstinence, during the study, is not breast feeding, and has had a negative urine pregnancy test within 24 hours prior to receiving the first dose of study medication.
3. The subject has been diagnosed as having OA of the knee for at least six months, as defined by the modified American College of Rheumatology (ACR) criteria.
4. The subject is functional class I, II or III according to the Steinbrocker criteria.
5. The subject is experiencing symptoms of OA (pain in the index knee) at the time of the Baseline visit (i.e., Patient’s assessment of arthritis pain based on 100mm VAS is within 40-90 mm).
6. The subject is anticipated to require continuous treatment with an anti-inflammatory or analgesic to control arthritis symptoms throughout the study.
7. The subject agrees not to drink excessively during the course of the study.
8. The subject has provided written informed consent before undergoing any study procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. The subject has any concomitant inflammatory rheumatic condition such as gout or other physical condition which may interfere with the assessment of OA such as acute joint trauma at the index joint.
2. The subject has an anticipated need for any surgical or any other invasive procedure to be performed on the index joint during the course of the study.
3. The subject has received oral, intramuscular, intravenous, intra-articular or soft tissue injections of corticosteroids within four weeks prior to the first dose of study medication.
4. The subject has received an intra-articular injection of corticosteroids in the Index Joint within three months or an intra-articular injection of a hyaluronic acid preparation in the Index Joint within six months prior to the first dose of study medication.
5. The subject is anticipated to require treatment with an anticoagulant, lithium, or chronic analgesic (other than study medication) during the course of the study.
6. The subject has an active malignancy or history of a malignancy other than a history of basal cell carcinoma that has been successfully treated or a history of other malignancies that have been surgically removed and which have no evidence of recurrence for at least five years before study enrollment.
7. The subject has been diagnosed as having or has been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication.
8. The subject has uncontrollable hypertension or diabetes, active GI disease (e.g., inflammatory bowel disease), chronic or acute renal or hepatic disorder, a significant coagulation defect, or a chronic condition, which, in the Investigator’s opinion, would preclude study participation.
9. The subject has within the past two years had a history of substance OR alcohol abuse or who in the investigator’s opinion have demonstrated addictive or substance abuse behavior.
10. The subject is unable to comply with the schedule of study visits and/or unable to complete the necessary subject evaluations.
11. The subject has received warfarin during the 30 days preceding the first dose of study medication.
12. The subject has an AST (SGOT), ALT (SGPT) or creatinine >1.5 mg/dL or BUN >1.2 x ULN any other laboratory abnormality considered by the Investigator to be clinically significant within 7 days before the Baseline visit.
13. The subject has a history of intolerance of diclofenac.
14. The subject has known hypersensitivity allergy and/or hypersensitivity to sulfonamides, COX-2 inhibitors, aspirin, lactose or NSAIDs.
15. The subject has taken any NSAIDs (oral or topical) or any analgesics within 48 hours (except for paracetamol within 8 hours) prior to the Baseline Arthritis Assessments. Subjects taking less than or equal to 100 mg aspirin daily for cardiovascular prophylaxis for at least 30 days before the first dose of study medication will be allowed to continue their regimen. Subjects must discontinue oxaprozin, piroxicam, meloxicam, and/or COX-2 inhibitors at least four days before the Baseline Arthritis Assessments.
16. The subject will receive any investigational medication within 30 days of the first dose of study medication or is scheduled to receive an investigational drug other than study medications described in this protocol during the course of this study.
17. The subject has previously been admitted to this study.
18. Subjects who are currently taking Glucosamine sulfate a

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Osteoarthritis of the knee
Classification code 10031161

Intervention(s)

Trade Name: Bextra 10mg film coated tablets
Product Name: Bextra 10 mg film coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: valdecoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10 mg-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Voltarol Tablets 50mg
Product Name: Voltarol Tablets 50mg
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: diclofenac sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 mg-
Pharmaceutical form of the placebo: Capsule, hard

Primary Outcome(s)

Primary end point(s): Patient's assessment of arthritis pain on Visual Analog Scale (VAS, 0-100 mm) at Week 6 (Visit 4).

Main Objective: The primary objective of this study is to demonstrate that valdecoxib 10 mg administered once daily for 6 weeks is not inferior to diclofenac sodium 50 mg administered three times daily for a total daily dose of 150 mg for 6 weeks in treating the signs and symptoms of OA of the knee.

Secondary Objective: To evaluate the safety and tolerability of valdecoxib 10 mg once daily compared to diclofencac sodium 50 mg three times daily on subjects with osteoarthritis of the knee.

Secondary ID(s)

N/A

A3471119