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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
History of Changes

July 13, 2009
August 28, 2012
August 2009
November 2010   (final data collection date for primary outcome measure)
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.
To evaluate the analgesic efficacy of 28 days of oral administration of AZD2066 compared to placebo in peripheral neuropathic pain patients with mechanical hypersensitivity (NP-MH). Pain intensity assessed by NRS score twice daily. [ Time Frame: Twice daily for 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00939094 on ClinicalTrials.gov Archive Site
  • 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.
  • To evaluate the response rate of patients to AZD2066 versus placebo, assessed as improvement of NRS of at least 30 and 50% respectively, and as PGIC of at least "much improved". [ Time Frame: NRS twice daily and PGIC every visit (approximately weekly). ] [ Designated as safety issue: No ]
  • To evaluate the effect of AZD2066 on different components of pain compared to placebo, assessed as change from baseline in BPI-SF and SF-MPQ. [ Time Frame: Throughout the study. ] [ Designated as safety issue: No ]
  • To evaluate safety and tolerability of AZD2066. [ Time Frame: Throughout the study. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
AZD2066 Neuropathic Pain - Mechanical Hypersensitivity
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neuropathic Pain
  • Mechanical Hypersensitivity
  • Drug: AZD2066
    Capsule, once daily
  • Drug: Placebo
    Capsule, once daily
  • Experimental: A
    Intervention: Drug: AZD2066
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
87
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00939094
D0475C00016
Not Provided
AstraZeneca
AstraZeneca
Quintiles
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
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP