Postherpetic NeuralgiaPhase 4NCT00904202
A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
A Phase 4 study testing Gabapentin + Lidoderm® in people with Postherpetic Neuralgia and Diabetic Neuropathy, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in United States.
Trial summary
Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Diabetic Neuropathy, Complex Regional Pain Syndrome
- What is being tested?
- Gabapentin + Lidoderm®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2003to Jun 2003
- Phase
- Phase 4
- 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
- Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)
- Patients with PHN must have had pain >3 months after rash healing
- Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
- Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
- Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
- Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration
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- Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration
- Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)
- Had never received an analgesic regimen that contained lidocaine or gabapentin
Who cannot join
- Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
- Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Altoona, Pennsylvania
Study site
Birmingham, Alabama
Study site
Hueytown, Alabama
Study site
New York, New York
Study site
Pembroke Pines, Florida
Study site
Phoenix, Arizona
Study site
Rochester, New York
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.
- Conditions
- Postherpetic Neuralgia, Diabetic Neuropathy, Complex Regional Pain Syndrome, Carpal Tunnel Syndrome, HIV Neuropathy, Idiopathic Sensory Neuropathy
- Being tested
- Placebo Capsules + Placebo Patch, Placebo capsules + Lidoderm®, Gabapentin + Placebo, Gabapentin + Lidoderm®, Gabapentin 300 mg capsules 1800 mg/day + placebo patch
- Medical subject headings
- Neuralgia, Postherpetic, Diabetic Neuropathies, Complex Regional Pain Syndromes, Carpal Tunnel Syndrome, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Capsules + Placebo PatchDrug
Also called Lidocaine patch 5%
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
Placebo capsules + Lidoderm®Drug
Also called Lidocaine patch 5%
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
Gabapentin + PlaceboDrug
Also called Lidocaine patch 5%
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
Gabapentin + Lidoderm®Drug
Also called Lidocaine patch 5%
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
Gabapentin 300 mg capsules 1800 mg/day + placebo patchDrug
Gabapentin 300 mg capsules 1800 mg/day + placebo patch
Gabapentin 1800 mg/day + Lidoderm patchDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo capsules + placebo patch | Placebo comparator | Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing Receives: Drug: Placebo Capsules + Placebo Patch |
| placebo capsules + Lidoderm patch (Lidocaine Group) | Experimental | Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing Receives: Drug: Placebo capsules + Lidoderm® |
| Gabapentin capsules 1800 mg/day + placebo patch | Active comparator | Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain Receives: Drug: Gabapentin + Placebo; Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch |
| Gabapentin capsules 1800 mg/day + Lidoderm patch | Other | Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain Receives: Drug: Gabapentin + Lidoderm®; Drug: Gabapentin 1800 mg/day + Lidoderm patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily pain intensity (BPI Questions 3,4,5, and 6)
Measured: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)
Secondary outcomes (6)
Pain Quality Assessment Scale (PQAS)
Investigator and Patient Global Impression of Change
Allodynia Testing
QoL; Symptom Checklist, pain interference with QoL
Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startJan 2003
- Primary completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sr Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904202
- Sponsor's protocol ID
- EN3220-009
- Status last verified
- Dec 2023
- First submitted
- 15 May 2009
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
- ClinicalTrials.gov ID
- NCT00904202
- Acronym / sponsor ID
- EN3220-009
- Conditions
- Postherpetic Neuralgia, Diabetic Neuropathy, Complex Regional Pain Syndrome, Carpal Tunnel Syndrome, HIV Neuropathy, Idiopathic Sensory Neuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jun 2003 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo capsules + placebo patch | Placebo comparator | Drug: Placebo Capsules + Placebo PatchPlacebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing |
| placebo capsules + Lidoderm patch (Lidocaine Group) | Experimental | Drug: Placebo capsules + Lidoderm®Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing |
| Gabapentin capsules 1800 mg/day + placebo patch | Active comparator | Drug: Gabapentin + Placebo, Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patchGabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain |
| Gabapentin capsules 1800 mg/day + Lidoderm patch | Other | Drug: Gabapentin + Lidoderm®, Drug: Gabapentin 1800 mg/day + Lidoderm patchGabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)
- Patients with PHN must have had pain >3 months after rash healing
- Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
- Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
- Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
Key exclusion criteria (3 listed)
- Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
- Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Capsules + Placebo PatchAlso: Lidocaine patch 5%Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). | Drug | placebo capsules + placebo patch |
| Placebo capsules + Lidoderm®Also: Lidocaine patch 5%Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). | Drug | placebo capsules + Lidoderm patch (Lidocaine Group) |
| Gabapentin + PlaceboAlso: Lidocaine patch 5%Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). | Drug | Gabapentin capsules 1800 mg/day + placebo patch |
| Gabapentin + Lidoderm®Also: Lidocaine patch 5%Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). | Drug | Gabapentin capsules 1800 mg/day + Lidoderm patch |
| Gabapentin 300 mg capsules 1800 mg/day + placebo patchGabapentin 300 mg capsules 1800 mg/day + placebo patch | Drug | Gabapentin capsules 1800 mg/day + placebo patch |
| Gabapentin 1800 mg/day + Lidoderm patch | Drug | Gabapentin capsules 1800 mg/day + Lidoderm patch |
Primary outcome
Average daily pain intensity (BPI Questions 3,4,5, and 6)
Time frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)
6 secondary outcomes
Pain Quality Assessment Scale (PQAS)
Investigator and Patient Global Impression of Change
Allodynia Testing
QoL; Symptom Checklist, pain interference with QoL
Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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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.
Sr Director study director
Endo USA Inc., a Keenova Therapeutics Company
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin + Lidoderm® in people with Postherpetic Neuralgia and Diabetic Neuropathy, run by Endo USA Inc., a Keenova Therapeutics Company at 7 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 9 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Average daily pain intensity (BPI Questions 3,4,5, and 6) (time frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.