Physician Sportsmed
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Physician Sportsmed · May 2015
Randomized Controlled Trial Multicenter StudyRandomized, double-blind, placebo-controlled study of the efficacy and safety of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen tablets for acute postoperative pain.
A fixed-dose combination biphasic immediate-release (IR)/extended-release (ER) hydrocodone bitartrate (HB)/acetaminophen (APAP) tablet is being developed for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. ⋯ IR/ER HB/APAP provided rapid, significant, and consistent analgesic efficacy over a period of 48 hours in an established model of acute pain and was tolerated with a safety profile similar to other low-dose opioids.
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Physician Sportsmed · Nov 2013
Randomized Controlled Trial Multicenter StudyIndomethacin submicron particle capsules provide effective pain relief in patients with acute pain: a phase 3 study.
Although frequently prescribed to relieve acute pain in patients, non-steroidal anti-inflammatory drugs (NSAIDs) are associated with dose-related gastrointestinal, cardiovascular, and renal complications. Investigational, submicron particle NSAIDs are being developed that could provide effective pain relief at lower doses than currently available oral NSAIDs. This is the first phase 3 study evaluating the analgesic efficacy and safety of lower-dose indomethacin submicron particle capsules in patients following elective surgery. ⋯ Some evidence of pain control was observed in patients as early as 2 hours following administration of indomethacin submicron particle capsules and was sustained throughout the treatment period. Indomethacin submicron particle capsules were generally well tolerated by patients. These results suggest that lower-dose indomethacin submicron particle capsules are a potentially promising treatment option for patients with acute pain.
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Physician Sportsmed · Sep 2011
Randomized Controlled Trial Multicenter StudyAn open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis.
To evaluate the long-term safety and tolerability of topical diclofenac sodium 1% gel (DSG) in the treatment of knee osteoarthritis (OA) for up to 12 months. ⋯ The long-term safety profile of DSG was consistent with previous 12-week studies, and DSG remained effective for a 1-year period.
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Physician Sportsmed · Feb 2011
Multicenter Study Comparative Study Clinical TrialEffectiveness and safety of diclofenac epolamine topical patch 1.3% for the treatment of acute pain due to back strain: an open-label, uncontrolled study.
The diclofenac epolamine topical patch 1.3% (DETP) is indicated for topical treatment of acute pain due to minor strains, sprains, and contusions. This exploratory, multicenter, open-label study evaluated effectiveness and safety of DETP in patients with acute pain due to back strain. ⋯ In this exploratory study, patients experienced well-tolerated relief for acute pain due to back strain, with ≥ 85% of patients and their investigators expressing satisfaction with DETP treatment.
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Physician Sportsmed · Apr 2009
Randomized Controlled Trial Multicenter StudyOriginal research: long-term efficacy and safety of periarticular hyaluronic acid in acute ankle sprain.
The objectives of this study were to determine the long-term efficacy and safety of periarticular hyaluronic acid (HA) injections in acute lateral ankle sprain. A randomized, controlled, prospective trial in a primary sports medicine and emergency practice involved 158 competitive athletes who suffered an acute grade 1 or 2 lateral ankle sprain, and who were randomly assigned within 48 hours of injury. Patients were randomly assigned at baseline to periarticular injection with HA + standard of care (rest, ice, elevation, and compression [RICE]) or placebo injection (PL) + standard of care (RICE) treatment at baseline assessment and day 4 after injury. ⋯ No serious AEs were recorded throughout follow-up. Periarticular HA treatment for acute ankle sprain was highly satisfactory in the short and long term versus PL. This was associated with reduced pain, more rapid return to sport, fewer recurrent ankle sprains, fewer missed days from sport, and with few associated AEs to 24 months.