Phase IV Study of FDA Approved, Once-Daily NCT01426230

Updated 06/14/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01426230
Other study ID #	81-0067
Secondary ID
Status	Completed
Phase	N/A
First received	August 29, 2011
Last updated	March 18, 2013
Start date	September 2011
Est. completion date	April 2012

Study information
Verified date	March 2013
Source	Depomed
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status	Completed
Enrollment	201
Est. completion date	April 2012
Est. primary completion date	March 2012
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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)	No

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT01124097` - Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia	Phase 3
	Completed	`NCT03974438` - Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.	N/A
	Recruiting	`NCT04144972` - Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain	N/A
	Completed	`NCT03447756` - Titration Study of ABX-1431	Phase 1
	Recruiting	`NCT06155487` - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects	Phase 1
	Recruiting	`NCT06218784` - A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.	Phase 1
	Completed	`NCT03584061` - Treatment of Chronic Postherpetic Pain With Fat Grafting	N/A
	Completed	`NCT01270828` - Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia	Phase 3
	Enrolling by invitation	`NCT06410222` - Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.
	Recruiting	`NCT05754190` - Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
	Completed	`NCT00475904` - A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)	Phase 2
	Completed	`NCT03765697` - A Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia	Phase 3
	Not yet recruiting	`NCT06130514` - The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block	N/A
	Completed	`NCT01748877` - Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia	Phase 2
	Active, not recruiting	`NCT06241820` - The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index	N/A
	Completed	`NCT03745404` - A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)	Phase 3