Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia

Depomed

Status: Completed

Conditions: Post Herpetic Neuralgia

Study type: Observational

Funder types: Industry

Identifiers

NCT01426230

81-0067

Details and patient eligibility

About

Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice

Full description

Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or Women 18 years or older who are suffering from PHN

Exclusion criteria

• Patient is Pregnant or a nursing mother
• Patient has hypersensitivity to gabapentin
• Patient has an estimated creatinine clearance of <30 mL/min or is in hemodialysis

Trial design

201 participants in 2 patient groups

Open Label

Description:

Cohort by age- - Patients \>70 Yrs old

Open label

Description:

Cohort by age- - Patients \< 70 Yrs old