Study of NGX-1998 for the Treatment of Postherpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeurogesX
ClinicalTrials.gov Identifier:
NCT01228838
First received: October 25, 2010
Last updated: September 6, 2012
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Postherpetic Neuralgia
Pain
Drug: NGX-1998
Drug: Placebo Liquid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by NeurogesX:

Primary Outcome Measures:
  • Percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-8. [ Time Frame: Weeks 2-8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 183
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NGX-1998, 10% w/w capsaicin Drug: NGX-1998
Capsaicin topical liquid to be applied for 5 minutes one time only.
Experimental: NGX-1998, 20% w/w capsaicin Drug: NGX-1998
Capsaicin topical liquid to be applied for 5 minutes one time only.
Placebo Comparator: Placebo liquid Drug: Placebo Liquid
Placebo topical liquid to be applied for 5 minutes one time only.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228838

  Show 35 Study Locations
Sponsors and Collaborators
NeurogesX
Investigators
Study Director: Trudy Vanhove, MD, PhD, MBA NeurogesX
  More Information

No publications provided

Responsible Party: NeurogesX
ClinicalTrials.gov Identifier: NCT01228838     History of Changes
Other Study ID Numbers: C204
Study First Received: October 25, 2010
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by NeurogesX:
postherpetic neuralgia
PHN
capsaicin
herpes zoster
shingles
analgesics
neuropathy

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014