Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01426230
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : March 21, 2013
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
Depomed

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

Condition or disease
Post Herpetic Neuralgia

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 201 participants
Time Perspective: Prospective
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 Start Date : September 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Group/Cohort
Open Label

Cohort by age-

- Patients >70 Yrs old

Open label

Cohort by age-

- Patients < 70 Yrs old




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients currently suffering from Post Herpetic Neuralgia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426230


Locations
Layout table for location information
United States, Alabama
Mobile, Alabama, United States
Tuscaloosa, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
United States, California
Fresno, California, United States
San Francisco, California, United States
United States, Connecticut
Fairfield, Connecticut, United States
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
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Bolingbrook, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Brighton, Massachusetts, United States
Worcestor, Massachusetts, United States
United States, Missouri
Jefferson City, Missouri, United States
St. Louis, Missouri, United States
United States, New Jersey
Tom River, New Jersey, United States
United States, North Carolina
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Altoona, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
United States, South Carolina
Mt. Pleasant, South Carolina, United States
United States, Tennessee
Cordova, Tennessee, United States
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
United States, Utah
Orem, Utah, United States
United States, Washington
Edmonds, Washington, United States
Sponsors and Collaborators
Depomed
Investigators
Layout table for investigator information
Study Director: Rekha Sathyanarayana Depomed Clinical Operations
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01426230    
Other Study ID Numbers: 81-0067
First Posted: August 31, 2011    Key Record Dates
Results First Posted: March 21, 2013
Last Update Posted: March 21, 2013
Last Verified: March 2013
Keywords provided by Depomed:
PHN
Post Herpetic Neuralgia
Shingles
HZ roster
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations