Postherpetic NeuralgiaPhase 4NCT00904020
A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
A Phase 4 study testing Lidoderm in people with Postherpetic Neuralgia and Diabetic Neuropathy, run by Endo USA Inc., a Keenova Therapeutics Company at 11 sites in United States.
Trial summary
Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Diabetic Neuropathy, Low Back Pain
- What is being tested?
- Lidoderm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2002to Nov 2002
- 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
- Were currently receiving an analgesic regimen that contained gabapentin
- Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
- Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit
- For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)
Who cannot join
- Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
- Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
- Had received trigger point injections within 14 days prior to study entry
- Had received Botox injections within 3 months prior to study entry
- Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
- Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Altoona, Pennsylvania
Study site
Birmingham, Alabama
Study site
Burr Ridge, Illinois
Study site
Cudahy, Wisconsin
Study site
Greenfield, Wisconsin
Study site
Hackensack, New Jersey
Study site
Marietta, Georgia
Study site
Overland Park, Kansas
Study site
Phoenix, Arizona
Study site
Plantation, Florida
Study site
West Bend, Wisconsin
About this study
Official title: A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.
- Conditions
- Postherpetic Neuralgia, Diabetic Neuropathy, Low Back Pain
- Being tested
- Lidoderm
- Medical subject headings
- Neuralgia, Postherpetic, Diabetic Neuropathies, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidodermDrug
Also called Lidocaine patach 5%
Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.
| Study group | Role | What they receive |
|---|---|---|
| (1) Lidoderm | Experimental | (1) Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Receives: Drug: Lidoderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Secondary outcomes (7)
Pain quality using the Neuropathic Pain Scale (NPS)
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Investigator and Patient Global Impression of Change
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Extent of numbness at the site of pain using the Numbness Questionnaire
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Patient Global Assessment of Pain Relief
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Pain interference (BPI Question 9)
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Patient Global Assessment of Patch Satisfaction
Measured: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
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 startJun 2002
- Primary completionNov 2002
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904020
- Sponsor's protocol ID
- EN3220-008
- Status last verified
- Dec 2023
- First submitted
- 15 May 2009
- Last updated
- 2 Jan 2024
- Results posted
- 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 Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
- ClinicalTrials.gov ID
- NCT00904020
- Acronym / sponsor ID
- EN3220-008
- Conditions
- Postherpetic Neuralgia, Diabetic Neuropathy, Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Nov 2002 (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 a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (1) Lidoderm | Experimental | Drug: Lidoderm(1) Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with 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 (4 listed)
- Were currently receiving an analgesic regimen that contained gabapentin
- Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
- Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit
- For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)
Key exclusion criteria (6 listed)
- Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
- Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
- Had received trigger point injections within 14 days prior to study entry
- Had received Botox injections within 3 months prior to study entry
- Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
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 |
|---|---|---|
| LidodermAlso: Lidocaine patach 5%Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. | Drug | (1) Lidoderm |
Primary outcome
Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
7 secondary outcomes
Pain quality using the Neuropathic Pain Scale (NPS)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Investigator and Patient Global Impression of Change
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Extent of numbness at the site of pain using the Numbness Questionnaire
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Patient Global Assessment of Pain Relief
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Pain interference (BPI Question 9)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Patient Global Assessment of Patch Satisfaction
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
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.
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
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.
Study Director study director
Endo USA Inc., a Keenova Therapeutics Company
11 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 Lidoderm in people with Postherpetic Neuralgia and Diabetic Neuropathy, run by Endo USA Inc., a Keenova Therapeutics Company at 11 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 4 inclusion and 6 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 11 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.
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 (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6) (time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)). 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.