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AZD2066 Neuropathic Pain - Mechanical Hypersensitivity (NP-MH)

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ClinicalTrials.gov Identifier: NCT00939094
Recruitment Status : Terminated
First Posted : July 14, 2009
Results First Posted : September 27, 2012
Last Update Posted : September 27, 2012
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Neuropathic Pain Mechanical Hypersensitivity Drug: AZD2066 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: AZD2066
Capsule, once daily
Placebo Comparator: B Drug: Placebo
Capsule, once daily



Primary Outcome Measures :
  1. 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) ]
    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 :
  1. Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 [ Time Frame: 28 days ]
    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

  2. Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 [ Time Frame: 28 days ]
    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

  3. Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28 [ Time Frame: 28 days ]
    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

  4. Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28 [ Time Frame: 28 days ]

    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.


  5. Change in SF-MPQ Affective Index From Baseline to Day 28 [ Time Frame: 28 days ]

    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.


  6. Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28 [ Time Frame: 28 days ]
    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.

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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939094


  Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Quintiles, Inc.
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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00939094     History of Changes
Other Study ID Numbers: D0475C00016
First Posted: July 14, 2009    Key Record Dates
Results First Posted: September 27, 2012
Last Update Posted: September 27, 2012
Last Verified: August 2012

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

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