Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain

NCT01117766 | Completed Results

• 1 other identifier: A9011015
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 5

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.

Conditions

Neuropathic Pain

Keywords

Methodology; Quantitative Sensory Testing; Neuropathies Pain; Pregabalin

Outcome Measures

Primary Outcomes (6)

• Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7

  Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7

  Dynamic area brush in cm\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \* perpendicular height); Σ ( ½ ri \* sin(45) r(i+1) ) = Σ ( (ri \* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7

  Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7

  Punctate allodynia area in cm\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \* perpendicular height); Σ ( ½ ri \* sin(45) r(i+1) ) = Σ ( (ri \* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7

  Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7

  Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

Secondary Outcomes (4)

• Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7

  Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

• Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7

  Week 4 (Visits 4 and 7) of each period

Study Arms (2)

Active drug

ACTIVE COMPARATOR

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin DRUG

Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients

Active drug

Placebo DRUG

BID dosing for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Pfizer Investigational Site

Vienna, A-1090, Austria

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Boulogne-Billancourt, 92100, France

Location

Pfizer Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

Pfizer Investigational Site

London, SW10 9NH, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: December 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 23, 2019
• Results First Posted: September 27, 2010

Record last verified: 2019-04

Locations

AU (1); FR (1); BE (1); GB (2)