- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928381
Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability
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
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a multi-center, randomized, two-part study in adults (ages 18-75 years) with Painful Diabetic Neuropathy (PDN).
In Part 1 of the study, eligible subjects will enter a 4-week Pain Training Period. During the Pain Training Period, subjects will receive three weekly in-clinic training sessions using repeated rating of experimental pressure pain stimuli. Subjects will receive feedback during this training and will be evaluated on their pain-reporting ability during each in-clinic session. Subjects with acceptable pain-reporting ability at the conclusion of the Pain Training Period will be eligible to enter Part 2 of the study. Subjects with unacceptable pain-reporting ability at the conclusion of the Pain Training Period will be discontinued from the study.
Part 2 of the study will consist of three consecutive double-blind crossover periods. Each crossover period will include 31 days of double-blind treatment. A follow-up visit will occur 14 ± 7 days after the last dose of study medication.
One of three treatments (placebo, pregabalin, or pregabalin + AZD5213) will be administered during each crossover treatment period, as determined by a randomly assigned treatment sequence.
Approximately 65 subjects will be screened in Part 1 of the study, in order to randomize up to approximately 32 subjects in Part 2 of the study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Clearwater, Florida, United States
- Research Site
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Orlando, Florida, United States
- Research Site
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Georgia
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Newnan, Georgia, United States
- Research Site
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Massachusetts
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Brockton, Massachusetts, United States
- Research Site
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Natick, Massachusetts, United States
- Research Site
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Watertown, Massachusetts, United States
- Research Site
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North Carolina
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Winston-Salem, North Carolina, United States
- Research Site
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Pennsylvania
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Duncansville, Pennsylvania, United States
- Research Site
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Philadelphia, Pennsylvania, United States
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo capsules
Capsules to match pregabalin and AZD5213
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Double blind placebo capsules to match AZD5213 and pregabalin
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Experimental: AZD5213 + pregabalin
AZD5213 in combination with pregabalin
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Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules)
Other Names:
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Active Comparator: pregabalin
pregabalin capsules
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Double blind pregabalin capsules to match AZD5213 and placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain
Time Frame: 3 weeks of treatment
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Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
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3 weeks of treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Pain
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- D3031C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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