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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03755934
Other study ID # D5680C00002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 19, 2018
Est. completion date June 29, 2023

Study information

Verified date September 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study investigating the effect of MEDI7352 on chronic pain in patients with painful diabetic neuropathy. 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. Subjects will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date June 29, 2023
Est. primary completion date June 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Key Inclusion criteria: - Male, or postmenopausal or surgically sterile female, 18 to 80 years of age - Body mass index of =42 kg/m2. - Chronic 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) NRS - willing and able to discontinue all NSAID or COX-2 analgesic therapy - currently be taking medication for the treatment of PDN. Subjects 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 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 subjects 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 subject's PDN pain, as judged by the investigator - Haemoglobin A1C greater than 8.5% (>8.5%).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MEDI7352
MEDI7352
Other:
Placebo
Placebo

Locations

Country Name City State
Denmark Research Site Gentofte
Hungary Research Site Balatonfüred
Hungary Research Site Budapest
Poland Research Site Bydgoszcz
Poland Research Site Gdansk
Poland Research Site Katowice
Poland Research Site Katowice
Poland Research Site Kraków
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 Warszawa
Poland Research Site Warszawa
Poland Research Site Wroclaw
Romania Research Site Bucuresti
Romania Research Site Calarasi
Romania Research Site Craiova
Romania Research Site Galati
Romania Research Site Targu-Mures
United Kingdom 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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Hungary,  Poland,  Romania,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the weekly average of the average daily pain scores Change in the weekly average of the average daily pain scores from the baseline week to Week 12 of MEDI7352 compared to placebo, as measured on an 11-point (0-10) NRS. from the baseline week to Week 12
Secondary Change in the weekly average of the average daily pain scores Change in the weekly average of the average daily pain score, as measured on an 11-point (0-10) NRS, from baseline to Weeks 2, 4, 6, 8, and 10 of treatment and the week before the follow-up visit (week 17). Weeks 2, 4, 6, 8, and 10 of treatment and the week before the follow-up visit (week 17).
Secondary Change in the weekly average of the average daily pain scores Percentage of subjects who have achieved =30% and =50% reductions in the weekly average of the average daily pain score from baseline during Weeks 4, 8, and 12 of treatment and the week before follow-up (week 17). from baseline during Weeks 4, 8, and 12 of treatment and the week before follow-up (week 17).
Secondary Change in Galer Neuropathic Pain Scale (NPS) Change in Galer Neuropathic Pain Scale (NPS) from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18). from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)
Secondary Change in Daily Sleep Interference Scale (DSIS) Change in Daily Sleep Interference Scale (DSIS) from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18). from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)
Secondary Proportion of subjects who have 'improved', 'much improved,' or 'very much improved' relative to baseline on the Patient Global Impression of Change (PGIC) Proportion of subjects who have 'improved', 'much improved,' or 'very much improved' relative to baseline on the Patient Global Impression of Change (PGIC) on Days 28, 56, and 84 of treatment and the follow-up visit (week 18). on Days 28, 56, and 84 of treatment and the follow-up visit (week 18).
Secondary Change in the 36-item Short-Form Health Survey (SF-36) Change in the 36-item Short-Form Health Survey (SF-36) from baseline to Day 84 of treatment. from baseline to Day 84 of treatment
Secondary Change in the amount of rescue medication used (in terms of dosage/day) Change in the amount of rescue medication used (in terms of dosage/day) from baseline to Week 12 of treatment. from baseline to Week 12 of treatment
Secondary incidence of AEs and SAEs from baseline up to 18 weeks
Secondary Area under the plasma concentration versus time curve of MEDI7352 from baseline up to 18 weeks
Secondary Peak Plasma Concentration (Cmax) of MEDI7352 from baseline up to 18 weeks
Secondary Summary of positive ADA against MEDI7352 from baseline up to 18 weeks
Secondary To characterise the dose-response relationship of MEDI7352 on chronic pain in subjects with PDN Change in the weekly average of the average daily pain scores from the baseline week to Week 12, as measured on an 11-point (0-10) NRS, versus dose. from baseline up to 12 weeks
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