N/A
N=31
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01117766 ↗Enrolled (actual)
31
Serious AEs
3.5%
Results posted
Sep 2010
Primary outcome: Primary: Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 — -1.09; -1.16; -1.31; -0.67 scores on a scale — p=0.7319
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 |
-1.09; -1.16; -1.31; -0.67 | 0.7319 |
| PRIMARY Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 |
-53.441; -49.180; -49.808; -18.921 | 0.6539 |
| PRIMARY Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 |
-0.133; 0.417; -1.356; 0.208; -0.200; -0.188 | 0.0071 sig |
| PRIMARY Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7 |
-75.571; -3.232; -75.834; -4.130 | 0.0300 sig |
| PRIMARY Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 |
-0.821; -1.402; -0.333; -1.313; -0.567; 0.125 | 0.7506 |
| PRIMARY Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 |
-1.100; -0.625; 0.400; -0.938; -0.908; -0.578 | 0.5502 |
| SECONDARY Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7 |
-1.456; -0.484; -1.397; -0.769 | 0.0132 sig |
| SECONDARY Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7 |
3.3; 3.4; 2.4; 3.8 | 0.6631 |
| SECONDARY Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7 |
-1.5; -0.4; -1.6; 0.0 | 0.1753 |
| SECONDARY Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7 |
-10.67; -7.72 | 0.4999 |
Summary
Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.
Eligibility Criteria
Inclusion Criteria
- Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.
- A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.
- Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.
Exclusion Criteria
- Patients who have undergone neurolytic or neurosurgical therapy.
- Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.
- Patients who have previously been treated with pregabalin.
Data sourced from ClinicalTrials.gov (NCT01117766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.