A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain
Summary
To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits
Description
Pain management in PD is a recognised unmet need. Estimates of incidence vary in the literature from 29% to 83%. The types and sources of pain experienced by PD patients vary and include: musculoskeletal pain, PD related chronic pain, fluctuation-related pain, nocturnal pain, coat-hanger pain, oro-facial pain and peripheral limb or abdominal pain (also including drug-induced pain). Whilst modifications to dosing of dopaminergic therapy represents the most common method of controlling some of these pain symptoms, this must be balanced against the worsening of side effects of increased doses of this treatment type.
Oxycodone hydrochloride and naloxone hydrochloride dihydrate combined oral prolonged release tablets (OXN PR), is the investigational product to be used in this study. OXN PR is a prolonged release tablet consisting of oxycodone and naloxone in a 2:1 ratio. Due to the local competitive antagonism of the opioid receptor-mediated oxycodone effect by naloxone in the gut, naloxone reduces opioid-associated bowel dysfunction.
The purpose of this study is to investigate whether effective pain control for the treatment of PD associated pain may be achieved with OXN PR. The secondary considerations for this study are to examine whether OXN PR may offer any additional benefits to the patients Quality of Life or symptoms of PD. If effective pain relief can be achieved with an analgesic without the side effects described in above, this could reduce the need to increase the dose of dopaminergic medications to manage pain, and therefore reduce the negative side effects of dopaminergic therapy described above. Given the prevalence of constipation in this patient population the bowel sparing effects of the OXN PR combination treatment may provide an ethical rationale for its use over that of other opioids.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Parkinson's Disease With Severe Pain
Intervention
Oxycodone/Naloxone Prolonged Release tablets, Placebo
Location
Fakultní nemocnice u sv. Anny v Brně Neurologická klinika
Brno
Czech Republic
Status
Recruiting
Source
Mundipharma Research GmbH & Co KG
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01439100
- Information obtained from ClinicalTrials.gov on November 07, 2012
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Mptp Poisoning
A condition caused by the neurotoxin MPTP which causes selective destruction of nigrostriatal dopaminergic neurons. Clinical features include irreversible parkinsonian signs including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP toxicity is also used as an animal model for the study of PARKINSON DISEASE. (Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986 Feb;36(2):250-8)
Parkinsonian Disorders
A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.
Parkinson Disease, Postencephalitic
Parkinsonism following encephalitis, historically seen as a sequella of encephalitis lethargica (Von Economo Encephalitis). The early age of onset, the rapid progression of symptoms followed by stabilization, and the presence of a variety of other neurological disorders (e.g., sociopathic behavior; TICS; MUSCLE SPASMS; oculogyric crises; hyperphagia; and bizarre movements) distinguish this condition from primary PARKINSON DISEASE. Pathologic features include neuronal loss and gliosis concentrated in the MESENCEPHALON; SUBTHALAMUS; and HYPOTHALAMUS. (From Adams et al., Principles of Neurology, 6th ed, p754)
Naltrexone
Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.
Clinical Trials
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone...
Oxycodone-naloxone in Relieving Opioid-related Constipation
The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in sympt...
The primary objectives are - to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor fun...
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the red...
The primary objective for the 12-week Titration-/Maintenance Period is: To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.
PubMed Articles
Objectives: This exploratory study in healthy volunteers investigated the effect of single doses of oxycodone on gastrointestinal (GI) transit time and the degree to which a single dose of naloxone re...
The role of opioid receptor antagonists in the treatment of opioid-induced constipation: a review.
Opioid-induced constipation (OIC) is associated with negative impact of opioid analgesics on opioid receptors located in the gut wall. Until recently, OIC was treated symptomatically only, with differ...
Abstract Objective To compare the cost effectiveness of prolonged release oxycodone/naloxone (OXN) tablets (Targinact*) and prolonged release oxycodone (OXY) tablets (OxyContin†) in patients with mo...
Morphine or oxycodone tablets for pain?
The opioids morphine and oxycodone are potent analgesics that are available as extended-release and immediate-release tablets. Indications are the same for both; i.e. severe acute pain and chronic pai...
High doses of oxycodone-naloxone combination may provide poor analgesia.
Several studies have shown that an oxycodone/naloxone combination (ratio 2:1) provides analgesia and less constipation in non-cancer patients receiving relatively low doses of this formulation. A case...
