Study of NGX-1998 for the Treatment of Postherpetic Neuralgia

Sponsor

NeurogesX (Industry)

Overall Status

Completed

CT.gov ID

NCT01228838

Collaborator

(none)

183

Enrollment

Locations

Arms

Duration (Months)

5.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Postherpetic Neuralgia Pain	Drug: NGX-1998 Drug: Placebo Liquid	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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)

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-8. [Weeks 2-8]

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 [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. [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. [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. [Week 8 and Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	NeurogesX Investigational Site	Huntsville	Alabama	United States
2	NeurogesX Investigational Site	Tucson	Arizona	United States
3	NeurogesX Investigational Site	Irvine	California	United States
4	NeurogesX Investigational Site	La Jolla	California	United States
5	NeurogesX Investigational Site	Napa	California	United States
6	NeurogesX Investigational Site	San Francisco	California	United States
7	NeurogesX Investigational Site	Santa Monica	California	United States
8	NeurogesX Investigational Site	New Port Richey	Florida	United States
9	NeurogesX Investigational Site	North Palm Beach	Florida	United States
10	NeurogesX Investigational Site	Sarasota	Florida	United States
11	NeurogesX Investigational Site	St. Petersburg	Florida	United States
12	NeurogesX Investigational Site	Marietta	Georgia	United States
13	NeurogesX Investigational Site	Boise	Idaho	United States
14	NeurogesX Investigational Site	Bloomington	Illinois	United States
15	NeurogesX Investigational Site	West Des Moines	Iowa	United States
16	NeurogesX Investigational Site	Kansas City	Kansas	United States
17	NeurogesX Investigational Site	Lexington	Kentucky	United States
18	NeurogesX Investigational Site	Shreveport	Louisiana	United States
19	NeurogesX Investigational Site	Hyannis	Massachusetts	United States
20	NeurogesX Investigational Site	Ann Arbor	Michigan	United States
21	NeurogesX Investigational Site	Minneapolis	Minnesota	United States
22	NeurogesX Investigational Site	Hattiesburg	Mississippi	United States
23	NeurogesX Investigational Site	Albany	New York	United States
24	NeurogesX Investigational Site	Rochester	New York	United States
25	NeurogesX Investigational Site	Hickory	North Carolina	United States
26	NeurogesX Investigational Site	Winston-Salem	North Carolina	United States
27	NeurogesX Investigational Site	Portland	Oregon	United States
28	NeurogesX Investigational Site	Altoona	Pennsylvania	United States
29	NeurogesX Investigational Site	San Antonio	Texas	United States
30	NeurogesX Investigational Site	Webster	Texas	United States
31	NeurogesX Investigational Site	Salt Lake City	Utah	United States
32	NeurogesX Investigational Site	Richmond	Virginia	United States
33	NeurogesX Investigational Site	Seattle	Washington	United States
34	NeurogesX Investigational Site	Wenatchee	Washington	United States
35	NeurogesX Investigational Site	Madison	Wisconsin	United States