Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination with Pregabalin in Subjects with PDN and Good Pain Reporting Ability

Study identifier:D3031C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Diabetic Neuropathy, Painful; Diabetic Neuropathies

Phase

Phase 2

Healthy volunteers

Study drug

AZD5213 + pregabalin, Placebo, pregabalin capsules

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Nov 2013

Primary Completion Date: 01 May 2015

Study Completion Date: 01 May 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2015 by AstraZeneca

Collaborators

Inclusion and exclusion 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).

No locations available

Arms	Assigned Interventions
Placebo Comparator: placebo capsules Capsules to match pregabalin and AZD5213	Drug: Placebo Double blind placebo capsules to match AZD5213 and pregabalin
Experimental: AZD5213 + pregabalin AZD5213 in combination with pregabalin	Drug: AZD5213 + pregabalin Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules) Other Name: pregabalin (LYRICA)
Active Comparator: pregabalin pregabalin capsules	Drug: pregabalin capsules Double blind pregabalin capsules to match AZD5213 and placebo Other Name: LYRICA (pregabalin)

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Anne Macek

610-296-1574