Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy
NCT ID: NCT03755934
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
112 participants
INTERVENTIONAL
2018-11-19
2023-06-29
Brief Summary
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The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period.
Participants will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.
Placebo
Participants will receive IV infusion of placebo as stated in arm description.
MEDl7352 Low Dose
Participants received 6 doses of IV MEDl7352 low dose during 12-week treatment period.
MEDI7352
Participants will receive IV infusion of MEDI7352 as stated in arm description.
MEDl7352 Medium Dose
Participants received 6 doses of IV MEDl7352 medium dose during 12-week treatment period.
MEDI7352
Participants will receive IV infusion of MEDI7352 as stated in arm description.
MEDI7352 High Dose
Participants received 6 doses of IV MEDl7352 high dose during 12-week treatment period.
MEDI7352
Participants will receive IV infusion of MEDI7352 as stated in arm description.
Interventions
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MEDI7352
Participants will receive IV infusion of MEDI7352 as stated in arm description.
Placebo
Participants will receive IV infusion of placebo as stated in arm description.
Eligibility Criteria
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Inclusion Criteria
* Body mass index of ≤ 42 kg/m\^2.
* Chronic painful diabetic neuropathy (PDN) persistent for 6 months or longer, not adequately controlled by standard of care treatments.
* Mean pain intensity score of ≥ 4, as measured on an 11-point (0-10) numerical rating scale (NRS).
* Willing and able to discontinue all non-steroidal anti-inflammatory drug (NSAID) or cyclooxygenase-2 (COX-2) analgesic therapy.
* Currently be taking medication for the treatment of PDN. Participants should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN).
Exclusion Criteria
* History of osteonecrosis, rapidly progressing osteoarthritis (OA), subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.
* Diagnosis of clinically significant OA currently affecting a major joint in the upper extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in participants for whom, in the opinion of the investigator, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.
* Chronic pain condition, other than PDN, that is likely to interfere with the evaluation of the participant's PDN pain, as judged by the investigator.
* Haemoglobin A1C greater than 10.0% (\> 10.0%).
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Gentofte Municipality, , Denmark
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Bydgoszcz, , Poland
Research Site
Gdansk, , Poland
Research Site
Katowice, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Lublin, , Poland
Research Site
Olsztyn, , Poland
Research Site
Poznan, , Poland
Research Site
Sochaczew, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bucharest, , Romania
Research Site
Călăraşi, , Romania
Research Site
Craiova, , Romania
Research Site
Galati, , Romania
Research Site
Târgu Mureş, , Romania
Research Site
Barnsley, , United Kingdom
Research Site
Blackpool, , United Kingdom
Research Site
Cannock, , United Kingdom
Research Site
Cardiff, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Prescot, , United Kingdom
Research Site
Stockton-on-Tees, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2018-002523-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5680C00002
Identifier Type: -
Identifier Source: org_study_id
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