Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date26 Jun 2009 |
评价服用试验药或安慰剂后对GERD患者四小时的食管pH值影响的双中心、随机、开放、安慰剂对照的双交叉研究
[Translation] A two-center, randomized, open-label, placebo-controlled, double-crossover study to evaluate the effects of the test drug or placebo on esophageal pH at four hours in patients with GERD
主要目的是比较复方海藻酸钠混悬液和相应的安慰剂,在给药后4小时期间内pH小于4的时间。 次要目的是确定和比较在给药后第1小时以及4小时期间pH低于4和5的发生次数和时间百分比。其他的次要目的包括比较在4小时期间的最长反流时间和DeMeester评分。
[Translation] The primary objective was to compare the time during which the pH of the compound sodium alginate suspension was less than 4 during the 4-hour period after administration with the corresponding placebo. The secondary objective was to determine and compare the number of occurrences and percentage of time during which the pH was less than 4 and 5 during the first hour and during the 4-hour period after administration. Other secondary objectives included comparison of the longest reflux time and DeMeester score during the 4-hour period.
一项随机、双盲、多中心、安慰剂平行对照临床研究以评价试验药对胃食管反流病的有效性和安全性
[Translation] A randomized, double-blind, multicenter, placebo-controlled parallel clinical study to evaluate the efficacy and safety of the experimental drug for gastroesophageal reflux disease
本项研究的主要目的是评估复方海藻酸钠混悬液与安慰剂相比,对于减缓胃食管反流病受试者烧心、反酸的总体症状的疗效
[Translation] The primary objective of this study was to evaluate the efficacy of sodium alginate compound suspension compared with placebo in alleviating the overall symptoms of heartburn and acid reflux in subjects with gastroesophageal reflux disease.
治疗胃食管反流病患者的4小时食管pH变化的多中心、随机、开放性、安慰剂对照、双周期交叉研究
[Translation] A multicenter, randomized, open-label, placebo-controlled, two-period crossover study of 4-hour esophageal pH changes in patients with gastroesophageal reflux disease
评估复方海藻酸钠双效双层咀嚼片(薄荷味)与相匹配的安慰剂相比较,缓解GERD患者的GERD症状的有效性。
[Translation] To evaluate the effectiveness of sodium alginate compound double-acting bilayer chewable tablets (mint flavour) compared with matching placebo in relieving GERD symptoms in patients with GERD.
100 Clinical Results associated with Beijing Hebikang Technology Development Co., Ltd.
0 Patents (Medical) associated with Beijing Hebikang Technology Development Co., Ltd.
100 Deals associated with Beijing Hebikang Technology Development Co., Ltd.
100 Translational Medicine associated with Beijing Hebikang Technology Development Co., Ltd.