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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01117766
• Date of registration: 04/05/2010
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
• Scientific 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
• Date of first enrolment: December 2006
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01117766
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Austria, Belgium, France, United Kingdom

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neuropathic Pain

Intervention(s)

Drug: Placebo

Drug: Pregabalin

Primary Outcome(s)

Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period]

Secondary Outcome(s)

Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7 [Time Frame: 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 [Time Frame: 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 [Time Frame: Week 4 (Visits 4 and 7) of each period]

Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7 [Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period]

Secondary ID(s)

A9011015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/09/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01117766