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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


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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