A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy

NCT ID: NCT01201317

Last Updated: 2014-04-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD2423, 150 mg

Tablets, 150 mg once daily in the morning.

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

150 mg tablet

AZD2423, 20 mg

Tablets, 20 mg once daily in the morning.

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

20 mg tablet

Placebo

Tablets, placebo, once daily in the morning.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2423

20 mg tablet

Intervention Type DRUG

AZD2423

150 mg tablet

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provision of signed informed consent form
* Males and female of non-child bearing potential patients aged 18 to 80 years
* Patients with neuropathic pain due to painful diabetic polyneuropathy.

Exclusion Criteria

* Other pain that may confound assessment of neuropathic pain
* History of treatment failure with more than three adequate trials of medication for neuropathic pain
* Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bror Jonzon

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Goodyear, Arizona, United States

Site Status

Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Tucson, Arizona, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

DeLand, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Orlando, Florida, United States

Site Status

Research Site

Sunrise, Florida, United States

Site Status

Research Site

Madisonville, Kentucky, United States

Site Status

Research Site

Willingboro, New Jersey, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Winston-Salem, North Carolina, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Winnipeg, Manitoba, Canada

Site Status

Research Site

Brampton, Ontario, Canada

Site Status

Research Site

Etobicoke, Ontario, Canada

Site Status

Research Site

Mississauga, Ontario, Canada

Site Status

Research Site

Lachine, Quebec, Canada

Site Status

Research Site

Laval, , Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D2600C00005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.