Status:
TERMINATED
Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy
Lead Sponsor:
AstraZeneca
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a study investigating the effect of MEDI7352 on chronic pain in participants with painful diabetic neuropathy. The study incudes a screening period of up to 45 days and a 12-week treatment pe...
Eligibility Criteria
Inclusion
- Key Inclusion criteria:
- Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
- 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).
- Key Exclusion criteria:
- Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology that is considered to be distinct from that of PDN, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator.
- 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%).
Exclusion
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03755934
Start Date
November 19 2018
End Date
June 29 2023
Last Update
September 19 2024
Active Locations (31)
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1
Research Site
Gentofte Municipality, Denmark, 2820
2
Research Site
Balatonfüred, Hungary, 8230
3
Research Site
Budapest, Hungary, 1036
4
Research Site
Bydgoszcz, Poland, 85-065