ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000013561

Ethics application status

Approved

Date submitted

16/12/2014

Date registered

9/01/2015

Date last updated

9/03/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

A Randomized, Double-Blind, Crossover, Phase IIa Study Comparing a Single-Application TPM (registered trademark)/Oxycodone Patch versus Vehicle Patch on pain intensity in the Topical Treatment of Patients with Postherpetic Neuralgia

Scientific title

A Randomized, Double-Blind, Crossover, Phase IIa Study Comparing a Single-Application TPM/Oxycodone Patch versus Vehicle Patch in the Topical Treatment of Patients with Postherpetic Neuralgia

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-herpetic neuralgia

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a Phase IIa, double-blind, randomized, 2 period crossover study in patients with PHN Eligible patients will be randomized in a 1:1 ratio to receive either POH001-05 (23.4 mg of oxycodone in a 40 cm2 patch) or placebo (vehicle) patch in Treatment Period 1. The patch will be applied on Visit Day 1 and will remain for 72 hours. Between Treatment Period 1 and 2, there will be a 10 day washout period. During Treatment Period 2, patients will cross over to receive the second treatment (i.e., either POH001-05 patch or vehicle patch), whichever treatment was not received during Treatment Period 1. The second patch will remain 72 hours. Each patch will be assessed for adherence and durability before it is removed by study site staff.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (vehicle patch)

Control group

Placebo

Outcomes

Primary outcome [1]

Change from baseline of average pain intensity scores assessed using NPRS between Treatment Period 1 and Treatment Period 2 at 24 hours and 72 hours.

Timepoint [1]

Changes in NPRS scores between Treatment Period 1 and Treatment Period 2 at 24 hours and 72 hours.

Secondary outcome [1]

Change from baseline of AVERAGE pain intensity scores assessed using the NPRS

Timepoint [1]

Change from baseline between Treatment Period 1 and Treatment Period 2 at 48 hours.

Secondary outcome [2]

Change from baseline of WORST pain intensity scores assessed using NPRS

Timepoint [2]

Change from baseline between Treatment Period 1 and Treatment Period 2 at 24 hours, 48 hours and 72 hours

Secondary outcome [3]

Change from baseline of AVERAGE daily pain intensity scores assessed using the NPRS

Timepoint [3]

Change from baseline between Treatment Period 1 and Treatment Period 2 from 72 hours until 168 hours after patch removal. During the washout phase after patch removal, the patients continue to take their daily pain scores to:
- assess any ongoing local effect after patch removal;
- keep patients in the habit of maintaining their daily diary.

Secondary outcome [4]

Change from baseline in Neuropathic Pain Symptom Inventory (NPSI)

Timepoint [4]

Change from baseline (prior to each patch application) to at least 30 minutes after each patch is removed

Secondary outcome [5]

Changes over time in Oxycondone/noroxycodone plasma concentration

Timepoint [5]

Baseline then 24 hours and 72 hours after patch application

Secondary outcome [6]

Changes over time in clinical laboratory parameters (haematology, biochemistry, urinalysis)

Timepoint [6]

Baseline and 72 hours after patch application

Secondary outcome [7]

Changes over time in Electrocardiogram results

Timepoint [7]

Baseline and 72 hours after patch application

Secondary outcome [8]

Changes over time in physical examination findings (general appearance, skin, head, eyes, ears, nose, throat, neck and thyroid, chest and lungs, heart/vascular, musculoskeletal, abdomen and vital signs)

Timepoint [8]

Baseline and 72 hours after patch application

Secondary outcome [9]

Changes over time in neurological findings (assessment of mental status, gross motor strength, sensory assessment, and reflexes)

Timepoint [9]

Baseline and 72 hours after patch application

Secondary outcome [10]

Signs of cardio-respiratory or central nervous system depression will be evaluated by sedation score monitoring

Timepoint [10]

24 hours and 72 hours after patch application

Secondary outcome [11]

Skin irritation assessment

Timepoint [11]

30 minutes after each patch removed

Eligibility

Key inclusion criteria

Patients with moderate to severe PHN pain present for at least 6 months after onset of herpes zoster (HZ) skin rash at the time of Screening.

Patients must have a NPRS average pain over the last 24 hours of more than 3 and less than 10 for 3 consecutive days prior to Baseline Visit

Patients must be willing and able to stop all protocol prohibited chronic current pain therapy for the duration of study

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Significant pain due to causes other than PHN

PHN painful areas located only on the face, above hairline of scalp, and / or in proximity to mucous membranes.

Any history of a dermatological condition or recurrent generalized skin disorder in the area to be treated within the last 5 years, including psoriasis, eczema or any other skin condition that might interfere with study assessments.

Current or recent use of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, aspirin, menthol, methyl salicylate, local anesthetics (including Lidoderm(registered trademark) patch), steroids, low-concentration capsaicin products on the painful areas within 3 days prior to Baseline assessment of pain and during the study.

Receiving treatment with more than one high dose medication for pain, such as anticonvulsants, within 10 days prior to Baseline assessment of pain and during the study.

Use of opioids (e.g. oxycodone, tramadol) within 10 days prior to Baseline assessment of pain and during the study.

Use of Central Nervous System (CNS) depressants including: neuroleptics, tranquillizers, skeletal muscle relaxants, sedating antihistamines within 30 days prior to Baseline assessment of pain and during the study. Exception: short acting night sedatives like benzodiazepines and non-benzodiazepines in small doses (e.g. sleep aids for insomnia) are allowed in consultation with the Medical Monitor (MM).

Antidepressant medications are allowed for anxiety and depression, if given on stable doses for a minimum of 6 months prior to Baseline assessment of pain and during the study. Such treatments should not be changed during the study without consultation with the MM. Exception: (TCA in dose up to 75 mg/ day or duloxetine [60 mg maximum daily] or venlafaxine [150 mg daily]) are permitted during the study

Use of neurotropin, N-methyl-D-aspartate receptor antagonists (dextromethorphan, ketamine, memantine, etc), muscle relaxants, sodium channel blockers (mexiletine, etc), centrally acting sympatholytic agents (clonidine, etc), and prostaglandin and related products (prescribed for PHN) 30 days prior to Baseline assessment of pain and during the study.

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)

PHN patients will be randomly allocated (via an online centrally randomization module) to receive either:
1. Oxycodone patch at treatment period 1 followed by vehicle (placebo) patch at treatment period 2
OR
2. Vehicle (placebo)patch at treatment period 1 followed by Oxycodone patch at treatment period 2

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A statistician who is not directly involved in the study or analysis of study results will prepare the study randomization code in a Statistical Analysis System (SAS) database. A randomization blocking scheme will be used to ensure that the balance between the treatment groups is maintained. Emergency Code Break will be possible in case of an emergency after consultation with the Medical Monitor.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Approximately 46 screened patients are needed (assuming an approximate 30-40 percent screen failure rate) to yield approximately 28 randomized patients (assuming a 20 percent drop-out rate) for a total of 22 evaluable patients (11 patients per treatment sequence). These calculations are based on a mean difference in NPRS at 72 hours of 1.4 units in the vehicle arm and 1.8 units in the TPM (registered trademark) /Oxycodone arm; a 1-sided test significance level of 0.05 with 80 percent power; standard deviation (SD) of 0.7; and a crossover analysis of variance (ANOVA) sqrt (MSE) of 0.495.

All statistical processing will be performed using Statistical Analysis System (SAS(registered trademark)) unless otherwise stated. Analyses will be of a descriptive nature. Descriptive statistics will consist of, summary statistics (number of observations, mean, standard error (SE), SD, minimum, median, and maximum) for continuous data and frequency counts and percentages for categorical data. For systemic exposure data, descriptive statistics will also include the coefficient of variation. Depending on the study population, data compiled up to the point of discontinuation will be used for analysis. Patients who are withdrawn prematurely from the study treatment will be included in all analyses (up to the date of withdrawal), regardless of the duration of treatment. There will be no imputation for missing data. Data will be summarized using descriptive statistics by treatment group. All data will be presented in patient data listings

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

19/01/2015

Actual

5/03/2015

Date of last participant enrolment

Anticipated

30/10/2015

Actual

4/11/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Recruitment hospital [1]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [2]

Royal North Shore Hospital - St Leonards

Recruitment hospital [3]

Westmead Hospital - Westmead

Recruitment hospital [4]

Linear Clinical Research - Nedlands

Recruitment hospital [5]

Hunter Clinical Research - Broadmeadow

Recruitment hospital [6]

Nucleus Network - Melbourne

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

6008 - Subiaco

Recruitment postcode(s) [3]

3004 - St Kilda Road Melbourne

Recruitment postcode(s) [4]

2292 - Hamilton North

Recruitment postcode(s) [5]

2010 - Darlinghurst

Recruitment postcode(s) [6]

2065 - Royal North Shore Hospital

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Phosphagenics Pty Ltd

Address [1]

11 Duerdin Street, Clayton VIC 3168

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Phosphagenics Pty Ltd

Address

11 Duerdin Street, Clayton VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Belberry Human Research Ethics Committee

Ethics committee address [1]

129 Glen Osmond Road Eastwood South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/11/2014

Approval date [1]

02/12/2014

Ethics approval number [1]

Summary

Brief summary

This is a research study to see if the TPM (registered trademark)/Oxycodone Patch (“study drug patch”) is safe and effective in treating participants with PHN compared to a patch which contains no Oxycodone but includes all of the other non-active components of the TPM (registered trademark)/Oxycodone Patch (“placebo patch” or “vehicle patch”). 
Oxycodone is an analgesic (pain reliever) which has been used, in tablet form, for the treatment of longstanding (chronic) moderate to severe pain, for many years. In tablet form it acts via the blood system. The patch also contains a form of vitamin E, called Tocopheryl Phosphate Mix (TPM), which can help some medications absorb across the skin.  
The purpose of this study is to find out whether the study drug patch provides pain relief when applied to an affected painful area in participants with PHN when compared to a vehicle patch. The study drug patch is designed to treat the area of reported pain ‘locally’ (at the site of pain in the skin) rather than ‘systemically’ (via the blood system).  This TPM helps the drug to enter through the skin. 
Study participants will be required to wear a patch containing oxycodone (study drug patch) on one occasion and a vehicle patch on another occasion. Participants will be required to wear each patch for 3 days (approx. 72 hours) at the site of worst PHN pain. 

In addition, this study will determine how safe the patch is:
 1. measuring the level of oxycodone that enters into blood (this is expected to be low and thus avoiding issues associated with euphoria, sedation and addiction)
2. monitoring symptoms that may be experienced while wearing the patch
3. observing results from assessments carried out during the course of the study

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Charles Brooker

Address

Royal North Shore Hospital,
Pain Management & Research Centre,
Douglas Building,
Royal North Shore Hospital
St. Leonards,
New South Wales 2065

Country

Australia

Phone

+61 2 9463 1533

Fax

+61 2 9463 1003

charles.brooker@sydney.edu.au

Contact person for public queries

Name

Ross Murdoch

Address

Phosphagenics Pty Ltd
11 Duerdin Street,
Clayton VIC 3168

Country

Australia

Phone

+61 3 9565 1142

Fax

rmurdoch@phosphagenics.com

Contact person for scientific queries

Name

Paul Gavin

Address

Phosphagenics Pty Ltd
11 Duerdin Street,
Clayton VIC 3168

Country

Australia

Phone

+61 3 9565 1139

Fax

pgavin@phophagenics.com

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Transdermal oxycodone patch for the treatment of postherpetic neuralgia: A randomized, double-blind, controlled trial.	2017	https://dx.doi.org/10.2217/pmt-2016-0067

N.B. These documents automatically identified may not have been verified by the study sponsor.

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