Clinical trial NCT01117766: Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Official title: A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Methodology
Quantitative Sensory Testing
Neuropathies Pain
Pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: Methodology to assess reproducibility and sensitivity of quantitative sensory testing

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.

Primary outcomes:
measure: Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Secondary outcomes:
measure: Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
timeFrame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
measure: Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7
timeFrame: Week 4 (Visits 4 and 7) of each period
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Boulogne Billancourt
country: France
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: