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

Viatris

Status and phase

Completed

Phase 1

Conditions

Nerve Pain

Treatments

Drug: Placebo

Drug: Pregabalin (Lyrica)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00654940

A0081187

Details and patient eligibility

About

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

Full description

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

Enrollment

25 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.