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Gelonghui Reports CMS' Successful Phase III Study of Methylthioninium Chloride Enteric-coated Sustained-release Tablets
[22/12/19]
SHENZHEN, CHINA, Dec 19, 2022 - (JCN Newswire) - Gelonghui released a Press Release on "China Medical System Holdings Limited's innovative product Methylthioninium Chloride Enteric-coated Sustained-release Tablets ('the Product') has obtained positive results for its Phase III clinical trial in China."
This is another breakthrough for the Product after China Medical System Holdings Limited ("CMS" or the "Group") had efficiently completed the enrollment of all 1,802 subjects for its China Phase III Clinical Trial in July this year, of which only 6 months (including the Spring Festival Holiday) was taken. The Group will actively move forward the Product's new drug application (NDA) in China.
In this China Phase III clinical trial, Methylthioninium Chloride Enteric-coated Sustained-release Tablets was compared to placebo with the purpose of assessing its safety and efficacy in the improvement of histologically confirmed non-polypoid colorectal lesions in subjects undergoing screening or surveillance colonoscopy for colorectal cancer. The research was led by Beijing Friendship Hospital, Capital Medical University and conducted in 22 sites nationwide. In total, 1802 subjects were randomized, 897 in the Product arm and 905 in the placebo arm. Of those, 872 in the product arm and 879 in the placebo arm were in the primary efficacy population (FAS: Full Analysis Set).
The study met the primary endpoint with very high statistical significance:
In the overall FAS, the proportion of patients with at least one histologically confirmed non-polypoid colorectal lesion was significantly higher in the Product group (445/872 subjects; 51.0%) as compared with placebo (362/879, 41.2%); (adjusted OR [95% CI]: 1.55 [1.27, 1.89]; P< 0.0001).
The study also confirmed the superiority of the Product versus placebo in several clinically meaningful endpoints:
a) Number of histologically confirmed non-polypoid colorectal lesions per patient
In the FAS, the per patient number of histologically confirmed non-polypoid colorectal lesions in the Product group was 0.9, as compared to 0.7 in the placebo group (difference between groups [95%CI]: 0.18 [0.07, 0.30] P=0.0022).
b) Number of histologically confirmed non-polypoid adenomas or cancers per patient
In the FAS, the per patient number of histologically confirmed non-polypoid adenomas or cancers in the Product group was 0.6 as compared to 0.5 in the placebo group (difference between groups [95%CI]: 0.12 ([0.03, 0.22] P=0.0125).
c) Detection rate of non-polypoid adenoma or cancer (NP-ADR)
In the FAS, 341 out of 872 patients (39.1%) were detected with at least one histologically confirmed non-polypoid adenoma in the Product arm. as compared with 274 out of 879 patients in the placebo group (31.2%) (OR [95%CI]: 1.43 [1.17, 1.75] P=0.0004).
d) Proportion of patients with at least one histologically confirmed
This is another breakthrough for the Product after China Medical System Holdings Limited ("CMS" or the "Group") had efficiently completed the enrollment of all 1,802 subjects for its China Phase III Clinical Trial in July this year, of which only 6 months (including the Spring Festival Holiday) was taken. The Group will actively move forward the Product's new drug application (NDA) in China.
In this China Phase III clinical trial, Methylthioninium Chloride Enteric-coated Sustained-release Tablets was compared to placebo with the purpose of assessing its safety and efficacy in the improvement of histologically confirmed non-polypoid colorectal lesions in subjects undergoing screening or surveillance colonoscopy for colorectal cancer. The research was led by Beijing Friendship Hospital, Capital Medical University and conducted in 22 sites nationwide. In total, 1802 subjects were randomized, 897 in the Product arm and 905 in the placebo arm. Of those, 872 in the product arm and 879 in the placebo arm were in the primary efficacy population (FAS: Full Analysis Set).
The study met the primary endpoint with very high statistical significance:
In the overall FAS, the proportion of patients with at least one histologically confirmed non-polypoid colorectal lesion was significantly higher in the Product group (445/872 subjects; 51.0%) as compared with placebo (362/879, 41.2%); (adjusted OR [95% CI]: 1.55 [1.27, 1.89]; P< 0.0001).
The study also confirmed the superiority of the Product versus placebo in several clinically meaningful endpoints:
a) Number of histologically confirmed non-polypoid colorectal lesions per patient
In the FAS, the per patient number of histologically confirmed non-polypoid colorectal lesions in the Product group was 0.9, as compared to 0.7 in the placebo group (difference between groups [95%CI]: 0.18 [0.07, 0.30] P=0.0022).
b) Number of histologically confirmed non-polypoid adenomas or cancers per patient
In the FAS, the per patient number of histologically confirmed non-polypoid adenomas or cancers in the Product group was 0.6 as compared to 0.5 in the placebo group (difference between groups [95%CI]: 0.12 ([0.03, 0.22] P=0.0125).
c) Detection rate of non-polypoid adenoma or cancer (NP-ADR)
In the FAS, 341 out of 872 patients (39.1%) were detected with at least one histologically confirmed non-polypoid adenoma in the Product arm. as compared with 274 out of 879 patients in the placebo group (31.2%) (OR [95%CI]: 1.43 [1.17, 1.75] P=0.0004).
d) Proportion of patients with at least one histologically confirmed
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