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Neuralgia, PostherpeticPhase 3NCT00335933

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 1 site in United States.

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
How many people
378 participants
Where
1 siteUnited States
Study dates
May 2006to Jul 2007
Phase
Phase 3
Are there results?
None posted in the registry

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 3 months after the healing of a herpes zoster skin rash (typically about 4 months after the rash first appears).
  • Patient has pain intensity score of at least 4 on the 11-point Likert numerical rating scale at screening. Potential patients should not be informed of the pain intensity eligibility criterion prior to screening or randomization.
  • Patients of childbearing potential must have a negative urine pregnancy test at screening/randomization, and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥ 1 year, must be specified in the patient's case report form (CRF).
  • Patient has a mean baseline week pain intensity score of at least 4 on the 11-point Likert scale at the end of a 1-week pre-treatment period and has completed at least 4 days of daily pain diary entries during the baseline week.
  • Patient must have a minimum washout period of greater than 5 times the half-life of the drug of any of the following medications: benzodiazepines, skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants and serotonin and norepinephrine reuptake inhibitors (SNRIs). Anticonvulsants, SNRIs, opiates and benzodiazepines should be tapered appropriately, using product label instructions as a guide.
  • Patients currently treated with gabapentin or 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 at least 7 days plus a 2-day or 3-day washout of gabapentin or pregabalin, respectively, prior to start of the baseline week.

Who cannot join

  • Patients who have previously not responded to treatment for PHN with gabapentin at doses of ≥ 1200 mg/day or pregabalin at doses ≥ 300 mg/day.
  • 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 17Show 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 of < 60 ml/min calculated using the Cockroft Gault method. If the patient fails this criterion, the Investigator may decide to conduct a 24-hour creatinine clearance test. The patient would be allowed to enroll in the study if the 24-hour test result is < 60 ml/min.
  • Patient has had a malignancy within the 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Development

    Austin, Texas, 78704

Other trials in United States

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 or twice 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) or twice daily (600 mg AM/1200 mg PM), 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
Keywords
Postherpetic Neuralgia (PHN)
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gabapentin extended-release tabletsDrug

What is being measured

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

  1. The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the average daily pain score from the baseline week to the final week of the efficacy treatment period (Treatment Week 10) in patients with PHN

  2. Daily pain scores will be measured using an electronic diary.

Secondary outcomes (1)

  1. Secondary objectives include assessment of changes from baseline in average daily sleep interference scores.

Timeline

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

  1. First posted12 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Study completionJul 2007

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
Factorial
Masking
Double blind
Enrolment
378 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335933
Sponsor's protocol ID
81-0045
Status last verified
Jun 2006
First submitted
8 Jun 2006
Last updated
2 Aug 2007
Results posted
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

  • Wallace MS, Irving G, Cowles VE. Gabapentin extended-release tablets for the treatment of patients with postherpetic neuralgia: a randomized, double-blind, placebo-controlled, multicentre study. Clin Drug Investig. 2010;30(11):765-76. doi: 10.2165/11539520-000000000-00000.

    PubMed 20818838

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 1 site 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 6 inclusion and 17 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 2 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the average daily pain score from the baseline week to the final week of the efficacy treatment period (Treatment Week 10) in patients with PHN. The study lists 2 primary outcomes in all. 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 NCT00335933, which also lists 2 linked publications.

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 2 Aug 2007.

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