Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability
Condition: Diabetic Neuropathy, Painful; Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Pain
Intervention: AZD5213 + pregabalin; Placebo; pregabalin capsules
Intervention description: Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules); Double blind placebo capsules to match AZD5213 and pregabalin; Double blind pregabalin capsules to match AZD5213 and placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting
      training program in which a painful stimulus will be applied to the subject's hand, and the
      subjects will be asked to report how painful the stimulus is. Over the course of the pain
      training sessions, feedback will be provided to the subject about how accurately they are
      reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke
      pain. Those subjects who have adequate pain reporting ability will be asked to continue into
      Part 2 of the study in which 3 different blinded study drugs will be administered to each
      subject, in a crossover design to compare whether or not the study drugs improve pain
      associated with diabetic neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male or female, age 18 to 75 years, inclusive, at Screen. 2. Subjects must provide
        informed consent in accordance with local regulations before the conduct of any
        study-related procedures. The informed consent should reflect the protocol stipulations
        concerning the use of contraception. 3. Diagnosis of Type 1 or Type 2 diabetes mellitus for
        at least 1 year prior to Screen. 4. Diabetes-related painful neuropathy for at least 6
        months prior to Screen. 5. Pain that began in the feet and is symmetric or nearly
        symmetric. 6. Diabetes has been clinically stable for at least 2 months prior to Screen,
        and between Screen and baseline (Day 35). 7. At Screen and baseline, score of at least 4 on
        Item 5 ("average pain") of the modified Brief Pain Inventory for patients with painful
        diabetic peripheral neuropathy (BPI-DPN). 8. Able to participate in all scheduled
        evaluations and to complete all required tests and procedures. 9. In the opinion of the
        investigator, the subject must be considered likely to comply with the study protocol and
        to have a high probability of completing the study.

        Exclusion Criteria:

        1. Known or suspected hypersensitivity to pregabalin. 2. Clinically important illness or
        infection (e.g., chronic, persistent, or acute infection) within 30 days prior to screen or
        between screen adn baseline. 3. Presence of any psychiatric or neurologic disorder or any
        other disorder or symptom, if, in the judgement of the investigator, the disorder or
        symptom is likely to confound interpretation of drug effect or affect the subject's ability
        to complete the study. Any clinically important abnormality, as determined by investigator
        at Screen or baseline, in physical or neurologic examination, vital sign, ECG, or clinical
        laboratory test results that could be detrimental to the subject, or could affect the
        subject's ability to complete the study. 4. Initiation or change in intensity or frequency
        of non-pharmacologic therapy for PDN, including psychotherapy, physical therapy, massage,
        acupuncture, acupressure, or chiropractic care, within 3 months prior to baseline).