Phase IV Study of FDA Approved, Once-Daily NCT01426230

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01426230
Other study ID #	81-0067
Secondary ID
Status	Completed
Phase	N/A
First received	August 29, 2011
Last updated	March 18, 2013
Start date	September 2011
Est. completion date	April 2012

Study information
Verified date	March 2013
Source	Depomed
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status	Completed
Enrollment	201
Est. completion date	April 2012
Est. primary completion date	March 2012
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Study in LOCF VAS	Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis	8 weeks (Baseline and Week 8)	No

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