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

March 18, 2013 updated by: Depomed

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Sun City, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Fresno, California, United States
      • San Francisco, California, United States
    • Connecticut
      • Fairfield, Connecticut, United States
    • Florida
      • Lauderdale Lakes, Florida, United States
      • Naples, Florida, United States
      • North Palm Beach, Florida, United States
      • Ormond Beach, Florida, United States
      • Palm Beach, Florida, United States
      • Sunrise, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Bolingbrook, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Massachusetts
      • Brighton, Massachusetts, United States
      • Worcestor, Massachusetts, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • St. Louis, Missouri, United States
    • New Jersey
      • Tom River, New Jersey, United States
    • North Carolina
      • Hickory, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Altoona, Pennsylvania, United States
      • Wyomissing, Pennsylvania, United States
    • South Carolina
      • Mt. Pleasant, South Carolina, United States
    • Tennessee
      • Cordova, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Bedford, Texas, United States
      • Corpus Christi, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Orem, Utah, United States
    • Washington
      • Edmonds, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients currently suffering from Post Herpetic Neuralgia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Open Label

Cohort by age-

- Patients >70 Yrs old
Open label

Cohort by age-

- Patients < 70 Yrs old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Study in LOCF VAS
Time Frame: 8 weeks (Baseline and Week 8)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Depomed

Investigators

  • Study Director: Rekha Sathyanarayana, Depomed Clinical Operations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 29, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81-0067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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