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

Pfizer logo

Pfizer

Status

Completed

Conditions

Neuropathic Pain

Treatments

Drug: Placebo
Drug: Pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01117766
A9011015

Details and patient eligibility

About

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.

Full description

Methodology to assess reproducibility and sensitivity of quantitative sensory testing

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

31 participants in 2 patient groups, including a placebo group

Active drug
Active Comparator group
Treatment:
Drug: Pregabalin
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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