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

NCT00857623 | Completed Phase 2 Results

• 1 other identifier: D0475C00009
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Pain; Diabetic Neuropathy

Keywords

Pain; Diabetic Neuropathy; PDN; Analgesia; Efficacy

Outcome Measures

Primary Outcomes (1)

• Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment

  Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.

  From baseline to day 28

Secondary Outcomes (8)

• Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.

  From baseline to 28 days

• Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28

  28 days

• Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28

  28 days

• Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.

  28 days

• Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.

  From baseline to day 28.

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2066

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2066 DRUG

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

1

Placebo DRUG

Capsule, once daily

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (19)

Reserach Site

Bella Vista, Arkansas, United States

Location

Research Site

National City, California, United States

Location

Research Site

Walnut Creek, California, United States

Location

Research Site

Clearwater, Florida, United States

Location

Research Site

DeLand, Florida, United States

Location

Research Site

Lauderdale Lakes, Florida, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

Pembroke Pines, Florida, United States

Location

Research Site

Madisonville, Kentucky, United States

Location

Research Site

Owing Mills, Maryland, United States

Location

Research Site

Bingham Farms, Michigan, United States

Location

Research Site

Willingboro, New Jersey, United States

Location

Reasearch Site

Albany, New York, United States

Location

Research Site

Winston-Salem, North Carolina, United States

Location

Research Site

Indiana, Pennsylvania, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Pain; Diabetic Neuropathies; Agnosia

Interventions

AZD2066

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Biljana Lilja

  AstraZeneca R&D Södertälje151 85 Södertälje, Sweden

  STUDY DIRECTOR

• Charles E Argoff, MD

  Albany Medical , NY 12208, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 6, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 12, 2012
• Results First Posted: October 29, 2012

Record last verified: 2012-11

Locations

US (19)