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AZD2066 Neuropathic Pain - Mechanical Hypersensitivity (NP-MH)

This study has been terminated.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00939094
First received: July 13, 2009
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.


Condition Intervention Phase
Neuropathic Pain
Mechanical Hypersensitivity
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 to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment [ Time Frame: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall) ] [ Designated as safety issue: No ]
    Mean pain intensity for 5-day baseline period (morning Day -5 to evening 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 NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.


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

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

  • Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28 [ Time Frame: 28 days ] [ 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 SF-MPQ Affective Index From Baseline to Day 28 [ Time Frame: 28 days ] [ 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: 28 days ] [ 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 NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.

  • Change in BPI-SF Pain Interference From Baseline to Day 28 [ Time Frame: 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 NRS 0-10, where 0=No interference and 10=Interferes completely.


Enrollment: 87
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: AZD2066
Capsule, once daily
Placebo Comparator: B 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.
  • Male or non-fertile females
  • Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Exclusion Criteria:

  • Other pain that may confound assessment of neuropathic pain.
  • Diagnosis of any severe neurological disease.
  • History of significant psychiatric disease/condition and/or 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: NCT00939094

  Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Quintiles
Investigators
Study Director: Biljana Lilja AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
Principal Investigator: Brett Stacey Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00939094     History of Changes
Other Study ID Numbers: D0475C00016
Study First Received: July 13, 2009
Results First Received: August 28, 2012
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Pain, Mechanical Hypersensitivity
Allodynia
Efficacy
analgesia
Neuropathic

Additional relevant MeSH terms:
Hypersensitivity
Neuralgia
Immune System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014