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Neuralgia,PostherpeticPhase 3NCT00636636

Safety and Efficacy of Gabapentin in Postherpetic Neuralgia

A Phase 3 study testing Gabapentin Extended Release tablets in people with Neuralgia,Postherpetic, run by Depomed at 39 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuralgia,Postherpetic
What is being tested?
Gabapentin Extended Release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
452 participants
Where
39 sitesin 3 countries
Study dates
Mar 2008to Sep 2009
Phase
Phase 3
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

Who may be able to join

  • Men or women 18 years or older who have experienced pain for at least 6 months, but not more than 5 years after the healing of a herpes zoster skin rash(typically about 4 months after the rash first appears).
  • Patient has a pain intensity score of at least 4 on the 11-point Numerical Rating Scale (NRS). Patients should never be informed of the pain intensity criterion prior to screening or randomization.
  • Patients of child-bearing potential must have a negative serum pregnancy test at screening and a negative follow-up urine pregnancy test at randomization.
  • Patient has a mean baseline week pain intensity score of at least 4 on the 11-point NRS scale at the end of a 1-week baseline period and has completed at least 4 days of daily pain diary entries during the baseline week.
  • Patients must have a minimum washout period of greater than 5 times the half-life of the drug of several medications.
  • Patients currently treated with gabapentin pr pregabalin at screening may be eligible for the study, but must have a tapering period wherein the dose of gabapentin or pregabalin is reduced gradually over a period of 5 days followed by a two day washout prior to the Baseline Week.

Who cannot join

  • Patients who have previously not responded to treatment for PHN with gabapentin or pregabalin.
  • Patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
  • Patient is a nursing mother.
  • Patient has hypersensitivity to gabapentin.
  • Patient has had neurolytic or neurosurgical treatment for PHN.
  • Patient has severe pain from causes other than PHN.
Show all 20Show fewer
  • Patient has used injected anesthetics or steroids within 30 days of baseline.
  • Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
  • Patient is in an immunocompromised state.
  • Patient has an estimated creatinine clearance less than 50 ml/min.
  • Patient has had malignancy within past 2 years other than basal cell carcinoma.
  • Patient has had gastric reduction surgery.
  • Patient has severe chronic diarrhea, chronic constipation [unless attributed to drugs that will be washed out], uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
  • Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
  • Patient has a history of substance abuse within the past year.
  • Patient has a history of seizure (except for infantile febrile seizure) or is at risk of seizure due to head trauma.
  • Patient has a history of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
  • Patient has any other clinically significant medical or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
  • Continuing use of any concomitant medication excluded by Inclusion Criterion 5.
  • Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

United States36 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Canton, Ohio

  • Study site

    Cincinnati, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Daytona Beach, Florida

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Fargo, North Dakota

  • Study site

    Florissant, Missouri

  • Study site

    High Point, North Carolina

  • Study site

    Honolulu, Hawaii

  • Study site

    Jefferson City, Missouri

  • Study site

    Kettering, Ohio

  • Study site

    Lancaster, California

  • Study site

    Little Rock, Arkansas

  • Study site

    Longview, Texas

  • Study site

    Los Angeles, California

  • Study site

    Marietta, Georgia

  • Study site

    Murrells Inlet, South Carolina

  • Study site

    Naples, Florida

  • Study site

    New Port Richey, Florida

  • Study site

    Orlando, Florida

  • Study site

    Pelzer, South Carolina

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Pueblo, Colorado

  • Study site

    Shreveport, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    Tampa, Florida

  • Study site

    Tullahoma, Tennessee

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Warwick, Rhode Island

  • Study site

    West Yarmouth, Massachusetts

Other trials in United States

Russia2 sites

  • Study site

    All Over Russia

  • Study site

    Saint Petersburg

Other trials in Russia

Argentina1 site

  • Study site

    Buenos Aires

Other trials in Argentina

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia

Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.

Read the detailed description

The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN.

Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).

Being tested
Gabapentin Extended Release tablets, Placebo
Keywords
Postherpetic Neuralgia (PHN), shingles
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.

  • Gabapentin Extended Release tabletsDrug

    Once-Daily; 300 mg and 600 mg tablets

  • PlaceboDrug

    Once daily; 300 mg and 600 mg tablets

Study groups in NCT00636636
Study groupRoleWhat they receive
G-ERExperimentalGabapentin - Extended Release
Receives: Drug: Gabapentin Extended Release tablets
PlaceboPlacebo comparatorSugar pill
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score

    Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10).

    Measured: 10 weeks

Secondary outcomes (3)

  1. Patient Global Impression of Change (PGIC)

    Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2).

    Measured: 10 weeks

  2. Clinical Global Impression of Change (CGIC)

    Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2).

    Measured: 10 weeks

  3. Average Daily Sleep Interference Score

    Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10).

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionAug 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00636636
Sponsor's protocol ID
81-0062
Status last verified
Feb 2012
First submitted
21 Feb 2008
Last updated
22 Feb 2012
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gabapentin Extended Release tablets in people with Neuralgia,Postherpetic, run by Depomed at 39 sites in 3 countries.

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 6 inclusion and 20 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Russia, Argentina. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2012). 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?

Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score (time frame: 10 weeks). 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 NCT00636636, 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 22 Feb 2012.

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