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

NCT01928381 | Completed Phase 2 Results

• 1 other identifier: D3031C00001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Diabetic Neuropathy, Painful; Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain

  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)

  3 weeks of treatment

Study Arms (3)

placebo capsules

PLACEBO COMPARATOR

Capsules to match pregabalin and AZD5213

Drug: Placebo

AZD5213 + pregabalin

EXPERIMENTAL

AZD5213 in combination with pregabalin

Drug: AZD5213 + pregabalin

pregabalin

ACTIVE COMPARATOR

pregabalin capsules

Drug: pregabalin capsules

Interventions

AZD5213 + pregabalin DRUG

Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules)

Also known as: pregabalin (LYRICA)

AZD5213 + pregabalin

Placebo DRUG

Double blind placebo capsules to match AZD5213 and pregabalin

placebo capsules

pregabalin capsules DRUG

Double blind pregabalin capsules to match AZD5213 and placebo

Also known as: LYRICA (pregabalin)

pregabalin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Clearwater, Florida, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

Newnan, Georgia, United States

Location

Research Site

Brockton, Massachusetts, United States

Location

Research Site

Natick, Massachusetts, United States

Location

Research Site

Watertown, Massachusetts, United States

Location

Research Site

Winston-Salem, North Carolina, United States

Location

Research Site

Duncansville, Pennsylvania, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Joel Posener, MD - Head Early Clinical Development
• Organization: AstraZeneca Pharmaceuticals LP, Neuroscience Innovative Medicine Unit

CinicalTrialTransparency@astrazeneca.net

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 23, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-08

Locations

US (9)