A Phase II, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of topical lidocaine spray in patients with Postherpetic Neuralgia
- Conditions
- Postherpetic NeuralgiaNeurological - Other neurological disorders
- Registration Number
- ACTRN12618000852257
- Lead Sponsor
- Andros Pharmaceuticals Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Female of non-childbearing potential (ie, 12 months or more of spontaneous
amenorrhea, bilateral oophorectomy at least 6 months prior to
randomisation, hysterectomy with bilateral oophorectomy at least 6 months
prior to randomisation, or for females over 50 years of age, hysterectomy
without bilateral oophorectomy at least 6 months prior to randomisation).
2. Females of childbearing potential must be confirmed to be not pregnant at
screening.
3. Males with sexual partners or females of childbearing potential must agree to
use an effective contraceptive method (abstinence, birth control pills, rings or
patches, diaphragm, intrauterine device, condom, surgical sterilization,
vasectomy, or progestin implant or injection) from screening to the end of
study, and for 1 month after exiting the study.
4. Persistent pain for more than 3 months from the appearance of herpes zoster
rash that is not located on the face, above the scalp hairline, or in proximity to
mucous membranes.
5. Diagnosis of PHN based on medical history as judged by investigator.
6. Persistent neuropathic pain that involves at least 1 dermatome and covering
no more than 420 cm2
7. If the subject has been on stable dose(s) of oral analgesic medication for at
least 30 days prior to the screening visit, they need to be willing to maintain
the respective dose(s) and medication throughout the study.
8. Pain intensity score in the target area of >=4 at both screening and the
randomisation visit. The pain intensity score for a subject may be reevaluated
if it is not >=4 at the randomisation visit.
9. Skin is intact over the painful area to be treated.
1. Subject has systemic disease that would put him/her at an additional risk or limit his/her ability to participate in the study as judged by the investigator.
2. Subject has a history of human immunodeficiency virus, hepatitis C, or hepatitis B.
3. Subject has a history of malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years.
4. Subject has a history of mental illness or psychiatric illness such as dementia, depression, or schizophrenia, that can limit his/her ability to comply with study procedures as judged by the investigator.
5. Subject is unable to apply, or have a caregiver apply, study spray to the most painful skin segments twice a day as directed.
6. Subject has known sensitivity to lidocaine containing products.
7. Subject has active herpes zoster lesions or dermatitis.
8. Subject has other condition(s) that cause severe or chronic pain that may impair the self-assessment of the pain due to PHN as judged by the investigator.
9. Subject was treated in the area of PHN with a local anaesthetic within 14 days of Baseline or had a nerve block within 30 days of Baseline
10. Subject is receiving any prohibited medication or therapy and is unable to washout these medications or therapies for the duration of the study.
11. Subject has used capsaicin patches within 90 days of Baseline or has used other capsaicin preparations on a daily basis in the 90 days prior Baseline.
12. Pregnant or lactating females.
13. Subject has an active history of alcohol or drug abuse.
14. Subject has participated in any other investigational study within 30 days prior to screening.
15. Subject or subject’s direct family is employed by the sponsor or study staff.
16. Subject has any condition that would make him/her unsuitable for the study
in the opinion of the investigator or sponsor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to Day 21 in 11-point Numeric Rating Scale (NRS-11)<br>NRS-11 scores range from 0=no pain to 10=worst pain imaginable[Randomisation visit, Day 21 visit]
- Secondary Outcome Measures
Name Time Method Change from baseline to 60 min post-dose and Day 7 in NRS-11[60 min post-dose at Randomisation visit, Day 7 visit];Change from baseline to 60 min post-dose, Day 7, and Day 21 in Neuropathic Pain Symptom Inventory (NPSI)[60 min post-dose at Randomisation visit, Day 7 visit, Day 21 visit];Change from baseline to Day 7 and Day 21 in Quality of Life (SF36 Questionnaire)[Randomisation visit, Day 7 visit, Day 21 visit];Change from baseline to Day 21 in sleep quality (Pain and Sleep Questionnaire PSQ-3) [Randomisation visit, Day 21 visit];Proportion of Subjects Achieving 30% and 50% improvement in NRS-11 and NPSI at Day 21[Randomisation visit, Day 21 visit];Safety assessments: evaluation of Adverse Events (AE), discontinuation due to AEs, physical examination results, vital signs, clinical laboratory data 12-lead ECG[Randomisation visit, Day 7 visit, Day 21 visit]