Status:
COMPLETED
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Nerve Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00654940
Start Date
May 1 2008
End Date
February 1 2009
Last Update
February 9 2021
Active Locations (5)
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1
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4N1
2
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
3
Pfizer Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
4
Pfizer Investigational Site
Jönköping, Sweden, 551 85