Clinical trial NCT01426230: Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
Official title: A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Herpetic Neuralgia
Keywords: PHN
Post Herpetic Neuralgia
Shingles
HZ roster
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients currently suffering from Post Herpetic Neuralgia

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to End of Study in LOCF VAS
timeFrame: 8 weeks (Baseline and Week 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Fairfield
country: United States
state: Connecticut
city: Lauderdale Lakes
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: North Palm Beach
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Palm Beach
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Bolingbrook
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Brighton
country: United States
state: Massachusetts
city: Worcestor
country: United States
state: Massachusetts
city: Jefferson City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Tom River
country: United States
state: New Jersey
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Allentown
country: United States
state: Pennsylvania
city: Altoona
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Mt. Pleasant
country: United States
state: South Carolina
city: Cordova
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Edmonds
country: United States
state: Washington
Study officials:
affiliation: Depomed Clinical Operations
name: Rekha Sathyanarayana
role: STUDY_DIRECTOR
References:
citation: Mehta N, Bucior I, Bujanover S, Shah R, Gulati A. Relationship between pain relief, reduction in pain-associated sleep interference, and overall impression of improvement in patients with postherpetic neuralgia treated with extended-release gabapentin. Health Qual Life Outcomes. 2016 Apr 1;14:54. doi: 10.1186/s12955-016-0456-0.