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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00857623

Purpose

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

Condition	Intervention	Phase
Pain Diabetic Neuropathy	Drug: AZD2066 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in mean numerical rating scale (NRS) score from baseline to last 5 days of treatment [ Time Frame: Twice daily for 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patients with Patient Global Impression of Change (PGIC) socre of at least "much improved" (responder rate) at Day 28 [ Time Frame: Twice daily for 28 days ] [ Designated as safety issue: No ]
Patients with >=30% reduction from baseline in NRS pain intensity score (responder rate) at Day 28 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Patients with >=50% reduction from baseline in NRS pain intensity score (responder rate) at Day 28 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment:	334
Study Start Date:	February 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: AZD2066 Capsule, once daily
Placebo Comparator: 2	Drug: Placebo Capsule, once daily

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857623

Locations

United States, Arkansas
Reserach Site
Bella Vista, Arkansas, United States
United States, California
Research Site
National City, California, United States
Research Site
Walnut Creek, California, United States
United States, Florida
Research Site
Clearwater, Florida, United States
Research Site
Deland, Florida, United States
Research Site
Lauderdale Lakes, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Pembroke Pines, Florida, United States
United States, Kentucky
Research Site
Madisonville, Kentucky, United States
United States, Maryland
Research Site
Owing Mills, Maryland, United States
United States, Michigan
Research Site
Bingham Farms, Michigan, United States
United States, New Jersey
Research Site
Willingboro, New Jersey, United States
United States, New York
Reasearch Site
Albany, New York, United States
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Research Site
Indiana, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Biljana Lilja	AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
Principal Investigator:	Charles E Argoff, MD	Albany Medical , NY 12208, USA

More Information

No publications provided

Responsible Party:	Anders Neijber, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier:	NCT00857623 History of Changes
Other Study ID Numbers:	D0475C00009
Study First Received:	February 27, 2009
Last Updated:	June 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Pain
Diabetic Neuropathy
PDN
Analgesia
Efficacy

Additional relevant MeSH terms:

Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus

Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012