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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT01426230
First received: August 29, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition
Post Herpetic Neuralgia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Depomed:

Primary Outcome Measures:
  • Change From Baseline to End of Study in LOCF VAS [ Time Frame: 8 weeks (Baseline and Week 8) ] [ Designated as safety issue: No ]
    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


Enrollment: 201
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Open Label

Cohort by age-

- Patients >70 Yrs old

Open label

Cohort by age-

- Patients < 70 Yrs old


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426230

  Show 37 Study Locations
Sponsors and Collaborators
Depomed
Investigators
Study Director: Rekha Sathyanarayana Depomed Clinical Operations
  More Information

No publications provided

Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01426230     History of Changes
Other Study ID Numbers: 81-0067
Study First Received: August 29, 2011
Results First Received: January 11, 2013
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Depomed:
PHN
Post Herpetic Neuralgia
Shingles
HZ roster

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 28, 2014