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Completed

NCT Number: NCT00857623

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

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

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Key information

Conditions

Pain Agnosia Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Reserach Site, Bella Vista, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD2066

Drug

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

Placebo

Drug

Capsule, once daily

Primary outcomes

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

    Time frame: From baseline to day 28

    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 outcomes

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

    Time frame: From baseline to 28 days

    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.

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

    Time frame: 28 days

    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

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

    Time frame: 28 days

    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

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

    Time frame: 28 days

    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

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

    Time frame: From baseline to day 28.

    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.

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

    Time frame: From baseline to day 28.

    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.

  7. Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.

    Time frame: From baseline to day 28..

    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.

  8. Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.

    Time frame: From baseline to 28 days

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2009
Registry last updated
Nov 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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