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
Overview
- Phase
- Phase 2
- Intervention
- AZD2066
- Conditions
- Neuropathic Pain
- Sponsor
- AstraZeneca
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
A
Intervention: AZD2066
B
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28(28 days)
- Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28(28 days)
- Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28(28 days)
- Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28(28 days)
- Change in SF-MPQ Affective Index From Baseline to Day 28(28 days)
- Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28(28 days)
- Change in BPI-SF Pain Interference From Baseline to Day 28(28 days)