A Study To Assess The Ability Of A Crossover Study Design To Measure The Activity Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nerve Pain
Intervention: Pregabalin (Lyrica) (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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
Clinical Details
Official title: Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Study design: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Primary outcome: Numerical daily pain score (using 11-point Likert scale)
Secondary outcome: Neuropathic Pain Sympton Inventory (NPSI)Activity as captured by the Actiwatch Score device
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Linkoping 581 85, Sweden; Recruiting
Pfizer Investigational Site, Jonkoping 551 85, Sweden; Recruiting
Pfizer Investigational Site, Calgary, Alberta T2N 4N1, Canada; Not yet recruiting
Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada; Recruiting
Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada; Not yet recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2008
Ending date: March 2009
Last updated: October 13, 2008
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