Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

  • STATUS
    Recruiting
  • End date
    May 8, 2023
  • participants needed
    271
  • sponsor
    AstraZeneca
Updated on 3 November 2021
analgesics
body mass index
chronic pain
NSAID
administered intravenously
diabetic neuropathy
painful diabetic neuropathy

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

Details
Condition DIABETIC NEUROPATHY, Peripheral Neuropathy, painful diabetic neuropathy
Treatment Placebo, MEDI7352
Clinical Study IdentifierNCT03755934
SponsorAstraZeneca
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

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)

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%)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note