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Hidden Kits Used in Clinical Trials

A technology of clinical trials and kits, applied in the field of clinical trials, can solve problems such as uncomfortable clinical trials

Inactive Publication Date: 2016-09-28
SANOFI AVENTIS DEUT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, this concealment device is not suitable for clinical trials, in which the drug must be administered to patients by injection

Method used

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  • Hidden Kits Used in Clinical Trials
  • Hidden Kits Used in Clinical Trials
  • Hidden Kits Used in Clinical Trials

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0045] Such as figure 1 As shown, the concealment kit 10 includes a first concealment device 11 and a second concealment device 31 . The first and second concealment means 11, 31 have substantially the same external shape and geometry. Both devices 11 , 31 comprise an outlet 18 and two inlets 14 , 16 , namely a first inlet 14 and a second inlet 16 . The two inlets 14, 16 are to be coupled with first and second delivery means 20, 22 which may comprise filled syringes such as figure 1 as indicated. The syringes 20 , 22 respectively comprise a connector 21 , 23 corresponding to the connector 15 , 17 of the first and second inlet 14 , 16 of the first and second concealment means 11 , 31 .

[0046] Such as figure 1 As shown, the concealment devices 11, 31 differ from each other in that the concealment device 11 is intended for use with patients in the placebo group, while the concealment device 31 is intended for use with patients in the treatment group. For this purpose, the ...

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PUM

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Abstract

The invention relates to a concealment kit for administering a drug to a patient in a clinical trial, said concealment kit comprising: a first concealment device (11; 41; 61) having an opaque container (12; 42; 62) and having an outlet (18) for administering a liquid substance to a patient and having at least first and second inlets (14, 16), wherein said first inlet (14) is permanently connected to said outlet (18) in fluid communication, and wherein at least a second inlet (16) is not connected to said outlet (18); a second concealment device (31; 43; 63) having an opaque container (32; 42; 62), and having an outlet (18) for administering a liquid substance to a patient and having at least two inlets (14, 16), wherein said at least two inlets (14, 16) are in permanent fluid communication with said outlet (18).

Description

technical field [0001] The present invention relates to the field of clinical trials, and in particular to concealed kits for administering drugs to patients in clinical trials. The blinding kit is particularly suitable for concealing whether a drug or an inert substance is provided and administered to a patient. Background technique [0002] In a clinical study or trial, the effectiveness of a drug is demonstrated by treating a group of patients with the drug while providing a control group of patients with an inert or inactive substance, such as physiological saline, which acts essentially as a placebo. [0003] However, depending on the type of drug administration and depending on the general characteristics of the drug, it may not be acceptable to administer an inert substance to a patient. For example, if a parenteral drug product is characterized by a particular color, it would be unacceptable to stain a contrasting inert substance accordingly. In such cases, the adm...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M5/14
CPCA61M5/14A61B5/4848A61M5/002A61M5/20A61M5/31566A61M2005/3125A61M2202/0468
Inventor C·柯德斯
Owner SANOFI AVENTIS DEUT GMBH