Morphine Sulfate and Naltrexone Hydrochloride Extended Release Capsules in Patients with Chronic Osteoarthritis Pain
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
OBJECTIVE: To assess the efficacy and safety of morphine sulfate and naltrexone hydrochloride extended release capsules (EMBEDA; MS-sNT), which contain morphine sulfate pellets with a sequestered naltrexone core, in treating patients with chronic, moderate-to-severe osteoarthritis (hip or knee) pain. PATIENTS AND METHODS: This phase 3 study had an enriched-enrollment, randomized-withdrawal, double-blind, multicenter design. Patients (N = 547) were titrated to an effective dose of MS-sNT (20-160 mg/day). Responders (n = 344) were randomized to 12 weeks maintenance with an effective MS-sNT dose or were tapered to placebo over 2 weeks. The primary efficacy measure was the change from baseline (CFB) in diary average-pain scores (0-10 scale, Brief Pain Inventory [BPI]) from randomization to the last 7 days of the maintenance period. Secondary efficacy measures included the remaining BPI scores and Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. Opioid withdrawal symptoms were assessed by the Clinical Opiate Withdrawal Scale (COWS) and Subjective Opiate Withdrawal Scale (SOWS). The study ran from January 10, 2007 through November 8, 2007. RESULTS: MS-sNT maintained pain control better than placebo (mean CFB, diary average-pain score, -0.2 +/- 1.9 vs +/-0.3 +/- 2.1; P = 0.045). Change from baseline for MS-sNT pain-diary score (worst, least, average, current) was superior during the maintenance period visits, weeks 2 to 12 (P < 0.05). WOMAC composite score CFB was superior at most visits. MS-sNT was generally well tolerated, with a typical morphine safety profile. No patient taking MS-sNT as directed experienced withdrawal symptoms. CONCLUSION: MS-sNT provided effective analgesia in patients with chronic, moderate-to-severe osteoarthritis pain, with a safety profile typical of morphine-containing products. Naltrexone sequestered in MS-sNT had no clinically relevant effect when MS-sNT was taken as directed.
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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) | 0.001 | 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 | 0.001 |
| 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 it