Post Herpetic NeuralgiaNCT01426230
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
An observational study of Post Herpetic Neuralgia, run by Depomed at 37 sites in United States.
Trial summary
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Herpetic Neuralgia
- How many people
- 201 participants
- Where
- 37 sitesUnited States
- Study dates
- Sep 2011to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients currently suffering from Post Herpetic Neuralgia
Who may be able to join
- Men or Women 18 years or older who are suffering from PHN
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Study site
Allentown, Pennsylvania
Study site
Altoona, Pennsylvania
Study site
Austin, Texas
Study site
Bedford, Texas
Study site
Bolingbrook, Illinois
Study site
Brighton, Massachusetts
Study site
Cordova, Tennessee
Study site
Corpus Christi, Texas
Study site
Edmonds, Washington
Study site
Evansville, Indiana
Study site
Fairfield, Connecticut
Study site
Fresno, California
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Jefferson City, Missouri
Study site
Lauderdale Lakes, Florida
Study site
Lexington, Kentucky
Study site
Marietta, Georgia
Study site
Mobile, Alabama
Study site
Mt. Pleasant, South Carolina
Study site
Naples, Florida
Study site
North Palm Beach, Florida
Study site
Orem, Utah
Study site
Ormond Beach, Florida
Study site
Palm Beach, Florida
Study site
Phoenix, Arizona
Study site
Raleigh, North Carolina
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
St Louis, Missouri
Study site
Sun City, Arizona
Study site
Sunrise, Florida
Study site
Tom River, New Jersey
Study site
Tucson, Arizona
Study site
Tuscaloosa, Alabama
Study site
Worcestor, Massachusetts
Study site
Wyomissing, Pennsylvania
About this study
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 objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Read the detailed description
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
- Conditions
- Post Herpetic Neuralgia
- Keywords
- PHN, Post Herpetic Neuralgia, Shingles, HZ roster
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Cohort by age- - Patients >70 Yrs old | |
| Open label | Cohort by age- - Patients < 70 Yrs old |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks (Baseline and Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Herpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Depomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rekha Sathyanarayana, Study director, Depomed Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426230
- Sponsor's protocol ID
- 81-0067
- Status last verified
- Mar 2013
- First submitted
- 29 Aug 2011
- Last updated
- 21 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27037091
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01426230
- Acronym / sponsor ID
- 81-0067
- Conditions
- Post Herpetic Neuralgia
- Keywords
- PHN, Post Herpetic Neuralgia, Shingles, HZ roster
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- DepomedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 21 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Detailed description
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Label | – | –Cohort by age- - Patients >70 Yrs old |
| Open label | – | –Cohort by age- - Patients < 70 Yrs old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients currently suffering from Post Herpetic Neuralgia
Key inclusion criteria (1 listed)
- Men or Women 18 years or older who are suffering from PHN
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27037091Mehta 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.
Related trials for Post Herpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
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Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rekha Sathyanarayana study director
Depomed Clinical Operations
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Herpetic Neuralgia, run by Depomed at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of Study in LOCF VAS (time frame: 8 weeks (Baseline and Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.