Postherpetic NeuralgiaPhase 2NCT01228838
Study of NGX-1998 for the Treatment of Postherpetic Neuralgia
A Phase 2 study testing NGX-1998 in people with Postherpetic Neuralgia and Pain, run by NeurogesX at 35 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998 applied for 5 minutes for the treatment of postherpetic neuralgia (PHN). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postherpetic Neuralgia, Pain
- What is being tested?
- NGX-1998
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 35 sitesUnited States
- Study dates
- Oct 2010to Sep 2011
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 90 years of age, inclusive.
- Diagnosis of PHN with at least six (6) months of pain since shingles vesicle crusting.
- Average NPRS scores for PHN-associated pain during Days -14 to -4 of 4 to 9, inclusive.
- Intact, unbroken skin over the painful area(s) to be treated.
- If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Test Article Application Visit and willing to maintain medications at same stable dose(s) and schedule throughout the study.
- Female subjects with child-bearing potential must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, to be performed within 7 days of the Test Article Application Visit.
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- All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study.
- If breastfeeding, the subject should agree not to breastfeed their child after treatment on the treatment day.
- Be willing and able to comply with protocol requirements for the duration of study participation.
- Subjects must sign an informed consent form for this study approved by the Investigator's Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Who cannot join
- Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded.
- Unavailability of an effective medication for treatment related discomfort for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort.
- Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period.
- Recent use (within 21 days preceding the Test Article Application Visit [Day 0]) of any topically applied pain medication on the painful areas.
- Receipt of Qutenza® within 12 months of the Test Article Application Visit (Day 0). Subjects who have received Qutenza® 12 months or more before Test Article Application Visit (Day 0), and who did not respond should also be excluded.
- Participation in another drug research study within 30 days preceding the Test Article Application Visit (Day 0).
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- Current use of any Class I anti-arrhythmic drugs or III anti-arrhythmic drugs.
- Diabetes mellitus, unless well-controlled as evidenced by an HBA1c level less than or equal to nine percent (9%).
- A recent history of cardiovascular or cerebrovascular events or unstable hypertension, unless adequately controlled by medication.
- Significant pain of an etiology other than PHN, for example, compression-related neuropathies, fibromyalgia or arthritis.
- Painful PHN areas located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
- Any implanted medical device for the treatment of neuropathic pain.
- History of hypersensitivity to capsaicin, local anesthetics or any components of the CTLs, Cleansing Gel or the lidocaine (2.5%) / prilocaine (2.5%) topical anesthetic cream.
- Patients with glucose-6 phosphate dehydrogenase deficiencies.
- Significant ongoing or untreated abnormalities or conditions, including active malignancy defined as treatment required in the last five (5) years, that in the opinion of the Investigator would interfere with the ability to complete the study or the evaluation of AEs.
- Patients with congenital or idiopathic methemoglobinemia.
- Recent history of a significant medical-surgical intervention in the judgment of the Investigator; examples include but are not limited to major surgery or percutaneous angioplasty/coronary artery stent placement within the past 3 months, and receipt of immunosuppressive therapy within 3 months, prior to the Test Article Application Visit [Day 0].
- Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring subject's recall of average PHN pain level in the past 24 hours.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
NeurogesX Investigational Site
Albany, New York
NeurogesX Investigational Site
Altoona, Pennsylvania
NeurogesX Investigational Site
Ann Arbor, Michigan
NeurogesX Investigational Site
Bloomington, Illinois
NeurogesX Investigational Site
Boise, Idaho
NeurogesX Investigational Site
Hattiesburg, Mississippi
NeurogesX Investigational Site
Hickory, North Carolina
NeurogesX Investigational Site
Huntsville, Alabama
NeurogesX Investigational Site
Hyannis, Massachusetts
NeurogesX Investigational Site
Irvine, California
NeurogesX Investigational Site
Kansas City, Kansas
NeurogesX Investigational Site
La Jolla, California
NeurogesX Investigational Site
Lexington, Kentucky
NeurogesX Investigational Site
Madison, Wisconsin
NeurogesX Investigational Site
Marietta, Georgia
NeurogesX Investigational Site
Minneapolis, Minnesota
NeurogesX Investigational Site
Napa, California
NeurogesX Investigational Site
New Port Richey, Florida
NeurogesX Investigational Site
North Palm Beach, Florida
NeurogesX Investigational Site
Portland, Oregon
NeurogesX Investigational Site
Richmond, Virginia
NeurogesX Investigational Site
Rochester, New York
NeurogesX Investigational Site
Salt Lake City, Utah
NeurogesX Investigational Site
San Antonio, Texas
NeurogesX Investigational Site
San Francisco, California
NeurogesX Investigational Site
Santa Monica, California
NeurogesX Investigational Site
Sarasota, Florida
NeurogesX Investigational Site
Seattle, Washington
NeurogesX Investigational Site
Shreveport, Louisiana
NeurogesX Investigational Site
St. Petersburg, Florida
NeurogesX Investigational Site
Tucson, Arizona
NeurogesX Investigational Site
Webster, Texas
NeurogesX Investigational Site
Wenatchee, Washington
NeurogesX Investigational Site
West Des Moines, Iowa
NeurogesX Investigational Site
Winston-Salem, North Carolina
About this study
Official title: A Multicenter Randomized, Double-Blind, Controlled Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Two Capsaicin Concentration Variations of NGX-1998 (10% or 20% w/w) in Subjects With Postherpetic Neuralgia (PHN)
The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998 applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).
Read the detailed description
This study is a 12-week multicenter randomized, double-blind, controlled evaluation of the efficacy, safety and tolerability of NGX-1998 for the treatment of postherpetic neuralgia (PHN). Eligible subjects will have pain from PHN, with average numeric pain rating scale (NPRS) scores during screening of 4 to 9 (inclusive). Painful areas of up to 1500 cm2 will be treated during a single Test Article application. Subjects will be randomly assigned to receive NGX-1998 (10% or 20% w/w) or placebo according to an unequal allocation scheme of 2:2:1. Subjects will also be stratified by gender.
- Conditions
- Postherpetic Neuralgia, Pain
- Being tested
- NGX-1998, Placebo Liquid
- Keywords
- postherpetic neuralgia, PHN, capsaicin, herpes zoster, shingles, analgesics, neuropathy
- Medical subject headings
- Neuralgia, Postherpetic, Pain, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGX-1998Drug
Capsaicin topical liquid to be applied for 5 minutes one time only.
Placebo LiquidDrug
Placebo topical liquid to be applied for 5 minutes one time only.
| Study group | Role | What they receive |
|---|---|---|
| NGX-1998, 10% w/w capsaicin | Experimental | Not described Receives: Drug: NGX-1998 |
| NGX-1998, 20% w/w capsaicin | Experimental | Not described Receives: Drug: NGX-1998 |
| Placebo liquid | Placebo comparator | Not described Receives: Drug: Placebo Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-8.
Measured: Weeks 2-8
Secondary outcomes (4)
Absolute change and percent change from baseline in the "average pain for the past 24 hours" NPRS score at Week 8 and 12
Measured: Week 8 and Week 12
Absolute change and percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-12.
Measured: Weeks 2-12
Proportion of subjects with at least a 30% decrease from baseline in their "average pain for the past 24 hours" NPRS during Weeks 2-8, Weeks 2-12, at Week 8 and Week 12.
Measured: Weeks 2-12
Proportion of subjects with at least a 2 unit decrease from baseline in their "average pain for the past 24 hours" NPRS during Weeks 2-8, Weeks 2-12, at Week 8 and Week 12.
Measured: Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionSep 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trudy Vanhove, MD, PhD, MBA, Study director, NeurogesX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228838
- Sponsor's protocol ID
- C204
- Status last verified
- May 2011
- First submitted
- 25 Oct 2010
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Double-Blind, Controlled Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Two Capsaicin Concentration Variations of NGX-1998 (10% or 20% w/w) in Subjects With Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT01228838
- Acronym / sponsor ID
- C204
- Conditions
- Postherpetic Neuralgia, Pain
- Keywords
- postherpetic neuralgia, PHN, capsaicin, herpes zoster, shingles, analgesics, neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Oct 2010 (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.
The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998 applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).
Detailed description
This study is a 12-week multicenter randomized, double-blind, controlled evaluation of the efficacy, safety and tolerability of NGX-1998 for the treatment of postherpetic neuralgia (PHN). Eligible subjects will have pain from PHN, with average numeric pain rating scale (NPRS) scores during screening of 4 to 9 (inclusive). Painful areas of up to 1500 cm2 will be treated during a single Test Article application. Subjects will be randomly assigned to receive NGX-1998 (10% or 20% w/w) or placebo according to an unequal allocation scheme of 2:2:1. Subjects will also be stratified by gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NGX-1998, 10% w/w capsaicin | Experimental | Drug: NGX-1998 |
| NGX-1998, 20% w/w capsaicin | Experimental | Drug: NGX-1998 |
| Placebo liquid | Placebo comparator | Drug: Placebo Liquid |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between 18 and 90 years of age, inclusive.
- Diagnosis of PHN with at least six (6) months of pain since shingles vesicle crusting.
- Average NPRS scores for PHN-associated pain during Days -14 to -4 of 4 to 9, inclusive.
- Intact, unbroken skin over the painful area(s) to be treated.
- If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Test Article Application Visit and willing to maintain medications at same stable dose(s) and schedule throughout the study.
Key exclusion criteria (18 listed)
- Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded.
- Unavailability of an effective medication for treatment related discomfort for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort.
- Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period.
- Recent use (within 21 days preceding the Test Article Application Visit [Day 0]) of any topically applied pain medication on the painful areas.
- Receipt of Qutenza® within 12 months of the Test Article Application Visit (Day 0). Subjects who have received Qutenza® 12 months or more before Test Article Application Visit (Day 0), and who did not respond should also be excluded.
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 |
|---|---|---|
| NGX-1998Capsaicin topical liquid to be applied for 5 minutes one time only. | Drug | NGX-1998, 10% w/w capsaicin, NGX-1998, 20% w/w capsaicin |
| Placebo LiquidPlacebo topical liquid to be applied for 5 minutes one time only. | Drug | Placebo liquid |
Primary outcome
Percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-8.
Time frame: Weeks 2-8
4 secondary outcomes
Absolute change and percent change from baseline in the "average pain for the past 24 hours" NPRS score at Week 8 and 12
Time frame: Week 8 and Week 12
Absolute change and percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-12.
Time frame: Weeks 2-12
Proportion of subjects with at least a 30% decrease from baseline in their "average pain for the past 24 hours" NPRS during Weeks 2-8, Weeks 2-12, at Week 8 and Week 12.
Time frame: Weeks 2-12
Proportion of subjects with at least a 2 unit decrease from baseline in their "average pain for the past 24 hours" NPRS during Weeks 2-8, Weeks 2-12, at Week 8 and Week 12.
Time frame: Week 8 and Week 12
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 10 Sep 2012.
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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.
Trudy Vanhove, MD, PhD, MBA study director
NeurogesX
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGX-1998 in people with Postherpetic Neuralgia and Pain, run by NeurogesX at 35 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 10 inclusion and 18 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-8. (time frame: Weeks 2-8). 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 10 Sep 2012.