MedDataX Logo

Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

NCT ID: NCT00857623

Last Updated: 2012-11-12

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

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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

The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

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.

Pain Diabetic Neuropathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pain Diabetic Neuropathy PDN Analgesia Efficacy

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.

1

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, once daily

Interventions

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

AZD2066

Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.

Intervention Type DRUG

Placebo

Capsule, once daily

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 informed consent prior to any study specific procedures.
* Clinical diagnosis of painful diabetic neuropathy.
* non-fertile females

Exclusion Criteria

* Other pain that may confound assessment of neuropathic pain.
* Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
* History of psychotic disorders among first degree relatives.
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.

Biljana Lilja

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje151 85 Södertälje, Sweden

Charles E Argoff, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical , NY 12208, USA

Locations

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

Reserach Site

Bella Vista, Arkansas, United States

Site Status

Research Site

National City, California, United States

Site Status

Research Site

Walnut Creek, California, United States

Site Status

Research Site

Clearwater, Florida, United States

Site Status

Research Site

DeLand, Florida, United States

Site Status

Research Site

Lauderdale Lakes, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Orlando, Florida, United States

Site Status

Research Site

Pembroke Pines, Florida, United States

Site Status

Research Site

Madisonville, Kentucky, United States

Site Status

Research Site

Owing Mills, Maryland, United States

Site Status

Research Site

Bingham Farms, Michigan, United States

Site Status

Research Site

Willingboro, New Jersey, United States

Site Status

Reasearch Site

Albany, New York, United States

Site Status

Research Site

Winston-Salem, North Carolina, United States

Site Status

Research Site

Indiana, Pennsylvania, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Countries

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

United States

Other Identifiers

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

D0475C00009

Identifier Type: -

Identifier Source: org_study_id