MEDI7352 in Painful Diabetic Neuropathy
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects with Painful Diabetic Neuropathy
IRAS ID
252169
Contact name
Aliya Asher
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-002523-42
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is being done for research purposes. The study drug, MEDI7352, is being tested for the treatment of painful diabetic neuropathy, a condition causing pain and numbness in the legs or arms in diabetic patients. The purpose of this study is to learn more about the use of MEDI7352 for the treatment of painful diabetic neuropathy.
The study drug, MEDI7352, has not yet been approved by the European Medicines Agency (EMA) or other regulatory bodies - it is an experimental treatment.
The study drug will be compared to a placebo. A placebo is a treatment that looks exactly like the study drug but does not contain any active ingredient. In this study, subjects will receive the active study drug (MEDI7352) or placebo. Whether subjects receive the study drug or placebo will be decided randomly.
This study will be done in 3 groups (cohorts). In the first and second groups of this study, 1 out of every 2 participants (50%) will receive placebo. In the third group of this study, 17% of participants (about 1 out of every 5 participants) will receive placebo. If subjects receive MEDI7352, they will receive 1 of 4 dose levels: 5, 30, 90, or 150 µg/kg.
To make the study fair, study subjects and investigators will not know which group subjects have been assigned too.
The study will be done at about 30 sites in approximately 6 countries globally. About 271 participants will take part in this clinical study.REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0450
Date of REC Opinion
22 Oct 2018
REC opinion
Further Information Favourable Opinion