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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

183

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach

1 country

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

October 1, 2010

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

Last Updated

September 10, 2012

Status Verified

May 1, 2011

Enrollment Period

11 months

First QC Date

October 25, 2010

Last Update Submit

September 6, 2012

Conditions

Postherpetic Neuralgia Pain

Keywords

postherpetic neuralgiaPHNcapsaicinherpes zostershinglesanalgesicsneuropathy

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

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

Interventions

NGX-1998DRUG

Capsaicin topical liquid to be applied for 5 minutes one time only.

NGX-1998, 10% w/w capsaicinNGX-1998, 20% w/w capsaicin

Placebo LiquidDRUG

Placebo topical liquid to be applied for 5 minutes one time only.

Placebo liquid

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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.
+3 more criteria

Contact the study team to confirm eligibility.