Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
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
1 other identifier
observational
201
1 country
37
Brief Summary
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Shorter than P25 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 21, 2013
CompletedMarch 21, 2013
March 1, 2013
6 months
August 29, 2011
January 11, 2013
March 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Open Label
Cohort by age- \- Patients \>70 Yrs old
Open label
Cohort by age- \- Patients \< 70 Yrs old
Eligibility Criteria
Patients currently suffering from Post Herpetic Neuralgia
You may qualify if:
- Men or Women 18 years or older who are suffering from PHN
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Depomedlead
Study Sites (37)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Tuscaloosa, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Sun City, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Fairfield, Connecticut, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Naples, Florida, United States
Unknown Facility
North Palm Beach, Florida, United States
Unknown Facility
Ormond Beach, Florida, United States
Unknown Facility
Palm Beach, Florida, United States
Unknown Facility
Sunrise, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Bolingbrook, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Brighton, Massachusetts, United States
Unknown Facility
Worcestor, Massachusetts, United States
Unknown Facility
Jefferson City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Tom River, New Jersey, United States
Unknown Facility
Hickory, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Altoona, Pennsylvania, United States
Unknown Facility
Wyomissing, Pennsylvania, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Cordova, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Bedford, Texas, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Orem, Utah, United States
Unknown Facility
Edmonds, Washington, United States
Related Publications (1)
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.
PMID: 27037091DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of R&D
- Organization
- Depomed
Study Officials
- STUDY DIRECTOR
Rekha Sathyanarayana
Depomed Clinical Operations
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2011
First Posted
August 31, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
March 21, 2013
Results First Posted
March 21, 2013
Record last verified: 2013-03