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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00857623
First received: February 27, 2009
Last updated: November 8, 2012
Last verified: November 2012
  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 2

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:


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: From baseline to day 28 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28. [ Time Frame: From baseline to 28 days ] [ Designated as safety issue: No ]
    Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.

  • Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100

  • Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100

  • Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.

    Responder= Patient with a response of "much improved" or "very much improved" Responder rate= (no. of responders/total no. of patients)*100


  • Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28. [ Time Frame: From baseline to day 28. ] [ Designated as safety issue: No ]

    Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).

    Change from baseline (measured prior to randomization) to Day 28 was calculated.


  • Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28. [ Time Frame: From baseline to day 28. ] [ Designated as safety issue: No ]

    Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).

    Change from baseline (measured prior to randomization) to Day 28 was calculated.


  • Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28. [ Time Frame: From baseline to day 28.. ] [ Designated as safety issue: No ]
    Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.

  • Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28. [ Time Frame: From baseline to 28 days ] [ Designated as safety issue: No ]
    Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.


Enrollment: 127
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, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: AstraZeneca
ClinicalTrials.gov Identifier: NCT00857623     History of Changes
Other Study ID Numbers: D0475C00009
Study First Received: February 27, 2009
Results First Received: September 28, 2012
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Pain
Diabetic Neuropathy
PDN
Analgesia
Efficacy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
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 September 18, 2014