EUCTR2005-000149-12-HU
Active, not recruiting
Not Applicable
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee
DrugsCelebrex
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Research & Development Limited
- Enrollment
- 1120
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject is male or female outpatient, \= 40 years of age.
- •A female is eligible to participate in this study if she is of:
- •aNon\-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre\-menarchal or post\-menopausal); or,
- •bChild\-bearing potential has a negative pregnancy test and is not lactating at the Screening and Baseline/Randomisation Visits and agrees to satisfy one of the requirements listed in Appendix 2: Acceptable Methods of Contraception.
- •2\.Subject is able and willing to give written informed consent
- •3\.Subject is able to read, comprehend and record information required in the protocol e.g. complete assessments using an electronic device
- •4\.Meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee as defined by: knee pain and radiographic osteophytes and at least one of the following:
- •i.Age \> 50 years
- •ii.Morning stiffness \< 30 minutes in duration
- •iii.Crepitus on active motion of the weight\-bearing knee
Exclusion Criteria
- •1\.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX\-2 inhibitors, unless subject has subsequently taken at least two separate NSAIDs/COX\-2 inhibitors for at least 1 month without reaction. Intolerance of paracetamol/acetominophen. History of aspirin\-sensitive asthma or nasal polyps
- •2\.Any clinical or biological abnormality found at screen (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study (i.e. current malignancy, human immunodeficiency virus (HIV) infection, significant mental illness)
- •3\.History of gastroduodenal perforations and/or obstructions
- •4\.History of any gastric or duodenal surgery
- •5\.Active gastrointestinal (GI) ulceration of the upper GI tract within the previous 6 months, bleeding of the upper GI tract within the previous year (including hematemesis)
- •6\.History of lower GI bleeding (excluding haemorrhoids) within the past year
- •7\.History of inflammatory bowel disease
- •8\.Use of proton pump inhibitors (e.g., omeprazole, lansoprazole) at any dose for any period longer than 4 consecutive days during the month prior to study start or during the study unless the subject has a history of GI ulceration (\> 6 months prior to study start)
- •9\.Use of sucralfate or misoprostol
- •10\.Use of potent CYP3A4 inhibitors i.e. ritonavir, ketoconazole, itraconazole, saquinavir, nelfinavir, troleandomycin, azithromycin and erythromycin. Other CYP3A4 inhibitors are permitted
Outcomes
Primary Outcomes
Not specified
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