Diabetic Neuropathy, Painful; Diabetic Neuropathies Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With Painful Diabetic Neuropathy and Good Pain Reporting Ability
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Brockton | Massachusetts |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Natick | Massachusetts |
| United States | Research Site | Newnan | Georgia |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Watertown | Massachusetts |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in Items 3,4,6, and 7 of the BPI-DPN | Days 29-128: Part 2 | No | |
| Primary | Change in Item 5 of Brief Pain Inventory Diabetic Peripheral Neuropathy version (BPI-DPN) | This will be analyzed using a mixed linear model with " subject" as a random main effect factor, "period" as fixed main effect factor with three levels of "treament" as a fixed main effect factor with 3 levels. | average calculated over the last 3 days of each crossover | No |
| Secondary | Incidence and severity of Treatment Emergent Adverse Events | Incidence and severity of adverse events will be summarized separately for Part 1 and Part, as applicable | Days 1-28: Part 1; Days 29-128: Part 2 | Yes |
| Secondary | Vital signs ( blood pressure, heart rate, weight and temperature) | Changes in vital signs will be summarized separately for Part 1 and Part 2, as applicable | Days 1-28: Part 1; Days 29-128: Part 2 | Yes |
| Secondary | Clinical Laboratory Evaluations | Changes in clinical laboratory evaluations will be summarized separately for Part 1 and Part 2, as applicable | Days 1-28: Part 1; Days 29-128: Part 2 | Yes |
| Secondary | Medical Outcomes Study (Revised) Sleep Scale (MOS-R) | Changes in sleep quality will be summarized for Part 2 of the study | Days 29-128: Part 2 | Yes |
| Secondary | Columbia Suicide Severity Rating Scale (CSSR-S) | Changes in the CSSR-S will be summarized separately for Part 1 and Part 2, as applicable | Days 1-28: Part 1; Days 29-128: Part 2 | Yes |
| Secondary | Neuropathic Pain Symptom Inventory (NPSI) | Changes in NPSI ratings will be summarized for Part 2 of the study | Days 29-128: Part 2 | No |
| Secondary | Sleep Interference Scale (SIS) | Changes in SIS ratings will be summarized for Part 2 of the study | Days 29-128: Part 2 | Yes |