P4 (Pregabalin for Peripheral Posttraumatic Pain)

Viatris

Status and phase: Completed; Phase 4

Conditions: Neuralgia

Treatments: Drug: pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292188

A0081064

Details and patient eligibility

About

To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain

Enrollment: 255 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

Exclusion criteria

• Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
• NeP not due to trauma, and not peripheral pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: pregabalin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo