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Trial registered on ANZCTR


Registration number
ACTRN12618000852257
Ethics application status
Approved
Date submitted
10/05/2018
Date registered
21/05/2018
Date last updated
29/01/2020
Date data sharing statement initially provided
29/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 294823 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 307767 0
Condition category
Condition code
Neurological 306812 306812 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lidocaine spray 5% solution
Applied topically to intact skin twice a day, Each application up to 18 sprays (approximately 2.5 mL) is to be applied to the specified area(s) of up to 420cm2. For a treatment of 21 days.
Compliance will be monitored by the return and weighing of the investigation product and interviewing the subject of the usage during study visits
Intervention code [1] 301143 0
Treatment: Drugs
Comparator / control treatment
Placebo Spray: Vehicle without API (Lidocaine)
Applied topically to intact skin twice a day, Each application up to 18 sprays (approximately 2.5 mL) is to be applied to the specified area(s) of up to 420cm2. For a treatment of 21 days.
Control group
Placebo

Outcomes
Primary outcome [1] 305808 0
Change from Baseline to Day 21 in 11-point Numeric Rating Scale (NRS-11)
NRS-11 scores range from 0=no pain to 10=worst pain imaginable
Timepoint [1] 305808 0
Randomisation visit, Day 21 visit
Secondary outcome [1] 346646 0
Change from baseline to 60 min post-dose and Day 7 in NRS-11
Timepoint [1] 346646 0
60 min post-dose at Randomisation visit, Day 7 visit
Secondary outcome [2] 346647 0
Change from baseline to 60 min post-dose, Day 7, and Day 21 in Neuropathic Pain Symptom Inventory (NPSI)
Timepoint [2] 346647 0
60 min post-dose at Randomisation visit, Day 7 visit, Day 21 visit
Secondary outcome [3] 346648 0
Change from baseline to Day 7 and Day 21 in Quality of Life (SF36 Questionnaire)
Timepoint [3] 346648 0
Randomisation visit, Day 7 visit, Day 21 visit
Secondary outcome [4] 346649 0
Change from baseline to Day 21 in sleep quality (Pain and Sleep Questionnaire PSQ-3)
Timepoint [4] 346649 0
Randomisation visit, Day 21 visit
Secondary outcome [5] 346650 0
Proportion of Subjects Achieving 30% and 50% improvement in NRS-11 and NPSI at Day 21
Timepoint [5] 346650 0
Randomisation visit, Day 21 visit
Secondary outcome [6] 346856 0
Safety assessments: evaluation of Adverse Events (AE), discontinuation due to AEs, physical examination results, vital signs, clinical laboratory data 12-lead ECG
Timepoint [6] 346856 0
Randomisation visit, Day 7 visit, Day 21 visit

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised Randomisation system using EDC IRT system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation schedule generated by computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2018
Actual
11/07/2018
Date of last participant enrolment
Anticipated
1/10/2018
Actual
11/02/2019
Date of last data collection
Anticipated
Actual
18/03/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 299420 0
Commercial sector/Industry
Name [1] 299420 0
Andros Pharmaceuticals Pty Ltd
Country [1] 299420 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Andros Pharmaceuticals Pty Ltd
Address
59 Gipps St., Collingwood, VIC 3066
Country
Australia
Secondary sponsor category [1] 298706 0
None
Name [1] 298706 0
Address [1] 298706 0
Country [1] 298706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300320 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 300320 0
Ethics committee country [1] 300320 0
Australia
Date submitted for ethics approval [1] 300320 0
02/05/2018
Approval date [1] 300320 0
14/06/2018
Ethics approval number [1] 300320 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83286 0
Dr Charles Brooker
Address 83286 0
Level 2, Douglas Building, Royal North Shore Hospital, Reserve Rd. ST LEONARDS, NSW 2065
Country 83286 0
Australia
Phone 83286 0
+61294631500
Fax 83286 0
Email 83286 0
charles.brooker@sydney.edu.au
Contact person for public queries
Name 83287 0
Jason Hsu
Address 83287 0
Andros Pharmaceuticals Pty Ltd
59 Gipps St., Collingwood, VIC 3066
Country 83287 0
Australia
Phone 83287 0
+88636581866 ext.214
Fax 83287 0
Email 83287 0
chhsu@andros.com.tw
Contact person for scientific queries
Name 83288 0
Jason Hsu
Address 83288 0
Andros Pharmaceuticals Pty Ltd
59 Gipps St., Collingwood, VIC 3066
Country 83288 0
Australia
Phone 83288 0
+88636581866 ext.214
Fax 83288 0
Email 83288 0
chhsu@andros.com.tw

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.