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A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients | Clinical Trials | Clareo Health

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A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

NCT00654940•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents

Detailed Description

Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
•Patients during the screening week must have completed ≥ 4 daily pain scores and have an average daily pain score ≥ 4.
•Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.

Exclusion Criteria

•Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
•Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
•Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
•Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
•Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.

Locations (5)

Pfizer Investigational Site

Calgary, Alberta, Canada

Pfizer Investigational Site

Hamilton, Ontario, Canada

Pfizer Investigational Site

Sarnia, Ontario, Canada

Pfizer Investigational Site

Jönköping, Sweden

Pfizer Investigational Site

Linköping, Sweden

Key Dates

Start Date

May 1, 2008

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

February 9, 2021

Enrollment

ACTUAL participants

Conditions

Nerve Pain

Interventions

Pregabalin (Lyrica)

DRUG

Placebo

DRUG

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Nerve Pain

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RECRUITING

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NCT06402448

Muscle PainJoint Pain+1 more

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ACTIVE_NOT_RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Inclusion Criteria

Exclusion Criteria

Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

Prevalence of Muscle and Nerve and Joint Pain

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

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