Clinical trial NCT00857623: Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Diabetic Neuropathy
Keywords: Pain
Diabetic Neuropathy
PDN
Analgesia
Efficacy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
timeFrame: From baseline to day 28
Secondary outcomes:
measure: Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.
timeFrame: From baseline to 28 days
measure: Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
timeFrame: 28 days
measure: Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
timeFrame: 28 days
measure: Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.
timeFrame: 28 days
measure: Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.
timeFrame: From baseline to day 28.
measure: Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.
timeFrame: From baseline to day 28.
measure: Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.
timeFrame: From baseline to day 28..
measure: Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.
timeFrame: From baseline to 28 days
Other outcomes:
Locations:
city: Bella Vista
country: United States
facility: Reserach Site
state: Arkansas
city: National City
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Deland
country: United States
facility: Research Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Madisonville
country: United States
facility: Research Site
state: Kentucky
city: Owing Mills
country: United States
facility: Research Site
state: Maryland
city: Bingham Farms
country: United States
facility: Research Site
state: Michigan
city: Willingboro
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Reasearch Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Indiana
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
name: Biljana Lilja
role: STUDY_DIRECTOR
affiliation: Albany Medical , NY 12208, USA
name: Charles E Argoff, MD
role: PRINCIPAL_INVESTIGATOR
References: