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
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
Phosphagenics Pty Ltd
28 participants
Mar 5, 2015
Interventional
Conditions
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
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria9
- 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.
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Interventions
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.
Locations(6)
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ACTRN12615000013561