Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT00904605
Eligibility Criteria:
Inclusion Criteria:
1. Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence of OA (presence of osteophytes on x-ray and written evaluation)
2. Had functional capacity class rating of I, II, or III according to ACR classification
3. Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
4. Had discontinued use of all analgesic medications (including over-the-counter \[OTC\] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for non-study pain)
5. At baseline visit, patients were randomized to active treatment if they had an average daily pain intensity score for the index joint of 5 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately preceding the baseline visit; 0 is defined as "no pain" and 10 is defined as "pain as bad as ever imagined" as measured by Question 5 of the BPI and recorded in a diary.
6. At baseline visit, patients were randomized to active treatment if they had an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee
Exclusion Criteria:
1. Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of OA
2. Had elective surgery scheduled to occur during the 14-week study
3. Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that may confound study results
4. Had any other clinically significant joint disease or prior joint replacement surgery at the index joint
5. Had severe renal insufficiency (creatinine clearance of \<30 mL/min)
6. Had moderate or greater hepatic impairment
7. Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
8. Had a prior history of peptic ulcer disease and/or gastrointestinal bleeding
9. Were taking analgesic medications, glucosamine, or chondroitin that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
10. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period.
11. Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks)
12. Were taking a lidocaine-containing products that could not be discontinued during the study
13. Had previously failed treatment with Lidoderm analgesic patch for OA
14. Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry
15. Were unable to discontinue use of topic drugs applied to the knee
16. Had previously failed treatment with celecoxib or with two COX-2 specific inhibitors other than celecoxib
17. Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00904605
Study Brief:
Protocol Section:
NCT00904605