Poster 6: Duloxetine 60 to 120 mg Once Daily Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
Bibliographic record
Abstract
K. Piezer, Lilly USA, LLC, Employment; Lilly USA. Reduction of pain is crucial to the management of osteoarthritis (OA) as it is a common cause of disability in OA patients. Duloxetine is efficacious in treating diabetic peripheral neuropathic pain and fibromyalgia. In this study, duloxetine (60-120 mg once daily) was evaluated in the treatment of OA knee pain. 13-week, randomized, double-blind, placebo-controlled trial. Outpatients. Patients meeting American College of Rheumatology clinical and radiographic criteria for OA of the knee, with pain for ≥14 days each month for 3 months before study entry and mean 24-hour average pain score ≥4. Patients were randomized to duloxetine (N = 128) or placebo (N = 128) and stratified by nonsteroidal anti-inflammatory use. At week 7, patients (33/128) who did not respond to 60-mg dose (≤30% reduction in pain) increased their dose to 120 mg. The primary efficacy outcome was Brief Pain Inventory (BPI) 24-hour average pain, analyzed using a mixed-effects repeated measures approach. Secondary outcomes included Patient's Global Impressions-Improvement (PGI-I), Western Ontario and McMaster Universities (WOMAC) pain and physical functioning, Clinical Global Impressions-Severity (CGI-S), BPI-Severity and -Interference, and weekly 24-hour average pain. Tolerability was also assessed. Compared with placebo-treated patients, duloxetine-treated patients had significantly greater reductions from baseline on the primary outcome, BPI average pain, from visit 3 through visit 5 (P < .001). Compared with placebo, duloxetine significantly reduced the WOMAC total scores (P = .044), weekly 24-hour average pain (P = .008), and CGI-S (P = .009). The PGI-I was improved significantly in duloxetine treated patients from visit 3 through visit 5 (P ≤ .05). Frequency of nausea, constipation, and hyperhidrosis were significantly higher in duloxetine group compared with placebo (P ≤ .05). Significantly more duloxetine-treated patients discontinued due to adverse events (P = .002). Compared with placebo, duloxetine treatment effectively reduced the pain and improved function in patients with OA knee pain; it was well tolerated.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".