December 4, 2017
Viking Therapeutics reported results of a phase II study of VK5211 in patients who recently suffered a hip fracture. The trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients were randomized to receive once-daily VK5211 doses of 0.5mg, 1.0mg, 2.0mg or placebo for 12 weeks. All doses of VK5211 demonstrated statistically significant increases in total lean body mass, less head, the study’s primary endpoint. Placebo-adjusted increases in lean body mass were 4.8% at 0.5mg (p<0.005), 7.2% at 1.0mg (p<0.001) and 9.1% at 2.0mg (p<0.001). These corresponded to placebo-adjusted increases of 1.6kg at 0.5mg (p<0.005), 2.5kg at 1.0mg (p<0.001) and 3.1kg at 2.0mg (p<0.001). Further evaluation of exploratory functional endpoints is underway.
August 16, 2010
QRxPharma released positive results from a phase II trial of MoxDuo IV for the treatment of moderate to severe postoperative pain following hip replacement surgery. This double blind, active controlled study enrolled 40 subjects at two sites in Germany. Following hip replacement surgery, the subjects were randomized to intravenous MoxDuo (morphine and oxycodone) or morphine alone over a two-part, 48-hour treatment period. The first part consisted of a 65 minute dose-titration in which fixed doses were given once every five minutes until a strong analgesic effect occurred. This was followed by a 47 hour patient controlled analgesia (PCA) period in which patients could self administer a fixed amount of study drug as frequently as once every six minutes. During the initial 65 minute dose-titration period, sum of pain intensity (SPID) scores from baseline were 50% higher among patients in the MoxDuo arm compared to the morphine alone arm. In addition, 67% of subjects receiving MoxDuo reported good to excellent global improvement compared to 53% of those receiving morphine alone. During the entire 48 hour study period, SPID scores were 10% higher among MoxDuo arm compared to the morphine alone arm. PCA data also indicated that subjects in the MoxDuo study arm were able to achieve better pain relief faster and with fewer doses (13 doses versus 17 doses).
September 8, 2008
Daiichi Sankyo issued positive results from a phase II trial of DU-176b for the prevention of venous thromboembolism (VTE). This randomized, double-blind comparative study enrolled 903 subjects in Europe and North America undergoing total hip replacement surgery. The subjects received four doses of DU-176b (15, 30, 60 and 90 mg once daily) or the low molecular weight heparin, dalteparin. Data showed a statistically significant dose response in efficacy. Statistical significance in the percentage of VTE incidences following DU-176b treatment occurred in the 30, 60 and 90 mg arms (21.2%, 15.2% and 10.6%; respectively) versus 43.8% in the dalteparin arm (p<0.001). In addition, the observed bleeding rates were low across the groups. Based on the results, Daiichi Sankyo plans to commence phase III studies for DU-176b in atrial fibrillation before the end of 2008.
November 18, 2002
AstraZeneca reported positive results from a phase III trial of Exanta (ximelagatran) versus enoxaparin, a low-molecular-weight heparin for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Data showed Exanta significantly reduced the risk of proximal DVT and PE by 6.3% compared to 2.3% with enoxaparin. The randomized, double blind, double-dummy study included nearly 2,800 subjects worldwide, undergoing either total knee replacement or total hip replacement surgery. In the study, 1,377 subjects received Exanta and 1,387 received enoxaparin. There were no fatal or critical-site bleeding events in either group. However, excessive bleeding at the operative site, as judged by the investigator was more common in the group receiving Exanta (3 % vs. 1.2 %).
September 9, 2002
Results of the Penthifra Plus study involving 656 subjects undergoing surgery for hip fracture showed that Arixtra (fondaparinux) administered for four weeks significantly reduces the incidence of deep venous thrombosis (DVT), compared to Arixtra administered for one week. In the double-blind, placebo-controlled study, subjects were all given 2.5 mg Arixtra for seven days following surgery for hip fracture. On day seven, subjects were randomized into two groups, and for the remaining 21 days of treatment they either continued being given the study drug or were given placebo. At the end of the treatment period, the incidence of thromboembolic complications was 1.4% for the Arixtra group compared to 35% for the placebo group. This study of Arixtra was sponsored by Sanofi-Synthelabo and NV Organon.
May 20, 2002
Initial results from a phase III trial show that Emisphere Technologies' oral heparin did not demonstrate superior efficacy compared to Aventis' Lovenox (enoxaparin) in preventing deep vein thrombosis (DVT). The PROTECT trial included 2,288 subjects undergoing total hip replacement surgery. The goal of the trial was to demonstrate superior efficacy and comparable safety for oral heparin dosed postoperatively in a 30-day treatment regimen compared to injectable Lovenox dosed for a 10-day regimen. Total DVTs were determined by bilateral venography at 30 days following surgery. The company plans to re-evaluate their oral heparin program based on these results.