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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Detailed Description

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

Conditions

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Nerve Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Pregabalin (Lyrica)

Intervention Type DRUG

Oral, 75mg or 150mg capsules, BID

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, matched capsules, BID

Interventions

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Pregabalin (Lyrica)

Oral, 75mg or 150mg capsules, BID

Intervention Type DRUG

Placebo

Oral, matched capsules, BID

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No