Efficacy and Safety of a Once-Daily Morphine Formulation in Chronic, Moderate-to-Severe Osteoarthritis Pain: Results from a Randomized, Placebo-Controlled, Double-Blind Trial and an Open-Label Extension Trial

• Published in: Journal of pain and symptom management Vol. 23; no. 4; pp. 278 - 291
• Main Authors: Caldwell, Jacques R., Rapoport, Ronald J., Davis, Jeffrey C., Offenberg, Howard L., Marker, Howard W., Roth, Sanford H., Yuan, William, Eliot, Lise, Babul, Najib, Lynch, Pia Mikkelsen
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.04.2002; Elsevier Science
• Subjects: Aged; Analgesics; Analgesics, Opioid - administration & dosage; Analgesics, Opioid - adverse effects; Analgesics, Opioid - therapeutic use; Biological and medical sciences; controlled-release; Double-Blind Method; extended-release; Female; Humans; Male; Medical sciences; Middle Aged; Morphine - administration & dosage; Morphine - adverse effects; Morphine - therapeutic use; morphine sulfate; Neuropharmacology; once daily; osteoarthritis; Osteoarthritis - complications; Pain; Pain - drug therapy; Pain - etiology; Pain Measurement; Pharmacology. Drug treatments; randomized clinical trial; Sleep - drug effects; sustained-release; Pain; osteoarthritis; sustained-release; once daily; morphine sulfate; randomized clinical trial; extended-release; controlled-release; Human; Controlled release form; Toxicity; Treatment efficiency; Diseases of the osteoarticular system; Single dose; Oral administration; Controlled therapeutic trial; Morphine; Opiates; Arthritis; Narcotic analgesic; Joint; Chemotherapy; Treatment; Arthropathy; Double blind study; Single daily dose
• ISSN: 0885-3924; 1873-6513
• DOI: 10.1016/S0885-3924(02)00383-4

A randomized, 4-week, double-blind trial followed by an open-label extension trial assessed the efficacy and safety of a once-daily, extended-release morphine formulation (Avinza™ (previously referred to as Morphelan™)) in 295 patients with chronic, moderate-to-severe osteoarthritis pain who had failed to obtain adequate pain relief with NSAIDs and acetaminophen. Participants received one of four treatments: Avinza 30 mg once daily (QAM or QPM), MS Contin® 15 mg twice daily, or placebo twice daily. Patients (n =181) received Avinza QAM or QPM during the 26-week open-label extension trial and could increase their dose to optimize pain control. Avinza and MS Contin reduced pain and improved several sleep measures versus placebo. Analgesic efficacy was comparable between Avinza and MS Contin; however, Avinza QAM demonstrated greater improvements in overall quality of sleep. The most common adverse events were constipation and nausea. The majority of AEs occurred at a similar incidence among the active treatment groups.