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

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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

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
Drug Information available for: Gabapentin
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01426230     History of Changes
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:
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
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents