A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain

Phase 3

Completed

• Conditions: Parkinson's Disease With Severe Pain
• Interventions: Drug: Placebo; Drug: Oxycodone/Naloxone Prolonged Release tablets

• Registration Number: NCT01439100
• Lead Sponsor: Mundipharma Research GmbH & Co KG

Brief 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

Detailed 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 Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2011-10
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dummy tablet	Placebo	Placebo
OXN PR	Oxycodone/Naloxone Prolonged Release tablets	Oxycodone/Naloxone Prolonged Release tablets

Trial Locations

Locations (31)

Vaszary Kolos Kórház Esztergom; 🇭🇺 Esztergom, Hungary

Petz Aladár Megyei Oktató Kórház; 🇭🇺 Győr, Hungary

NZOZ Synapsa; 🇵🇱 Kielce, Poland

Krakowska Akademia Neurologii Sp. z o.o.; 🇵🇱 Krakow, Poland

USP Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain

Poliklinika Choceň Neuroligická ambulance; 🇨🇿 Chocen, Czech Republic

Neurologická ambulance; 🇨🇿 Policka, Czech Republic

CTC Rychnov nad Kněžnou s.r.o.; 🇨🇿 Rychnov nad Kněžnou, Czech Republic

Fakultní nemocnice u sv. Anny v Brně Neurologická klinika; 🇨🇿 Brno, Czech Republic

Fakultní nemocnice Plzeň Neurologická klinika; 🇨🇿 Plzeň-Lochotín, Czech Republic

Ruhr Universität Bochum St. Josef-Hospital; 🇩🇪 Bochum, Germany

Zentrum für Altersmedizin; 🇩🇪 Haag i. OB, Germany

Szent János Kórháza és Észak-budai Egyesített Kórházaik; 🇭🇺 Budapest, Hungary

Philipps-Universität; 🇩🇪 Marburg, Germany

Asklepios Fachklinikum Abteilung für Neurologie; 🇩🇪 Stadtroda, Germany

Spitalul Clinic de Neuropsihiatrie; 🇷🇴 Craiova, Jud. Dolj, Romania

City General Hospital, Pharmacy Dept, Newcastle Road; 🇬🇧 Stoke on Trent, United Kingdom

Fairfield General Hospital Pennine Acute NHS Trust; 🇬🇧 Bury Great Manchester, United Kingdom

Hospital General de Catalunya; 🇪🇸 Sant Cugat, Barcelona, Spain

Neurologie Berlin; 🇩🇪 Berlin-Steglitz, Germany

Uniklinik Leipzig; 🇩🇪 Leipzig, Germany

Uniklinik Ulm; 🇩🇪 Ulm, Germany

Paracelsus-Elena-Klinik; 🇩🇪 Kassel, Germany

Kenézy Kórház-Rendelőintézet Egészségügyi Szolgáltató Kft.; 🇭🇺 Debrecen, Hungary

Szent Pantaleon Kórház-Rendelőintézet Dunaújváros; 🇭🇺 Dunaújváros, Hungary

Bács-Kiskun Megyei Kórháza; 🇭🇺 Kecskemét, Hungary

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universtario La Paz; 🇪🇸 Madrid, Spain

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Royal Preston Hospital; 🇬🇧 Preston, United Kingdom

Universitätsmedizin Göttingen Georg-August-Universität; 🇩🇪 Göttingen, Germany