A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain
2 other identifiers
interventional
172
7 countries
31
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2011
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 6, 2014
February 1, 2014
1.8 years
September 21, 2011
February 5, 2014
Conditions
Keywords
Study Arms (2)
OXN PR
ACTIVE COMPARATOROxycodone/Naloxone Prolonged Release tablets
Dummy tablet
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Males and females, age of 25 years or over
- Able to provide written informed consent
- Primary diagnosis of Parkinson's disease Stage II-IV)
- Graded as having severe pain
- An average pain score of 6 or above on an 11 point NRS, over the previous 7 days
- Female subjects willing to use an adequate and highly effective method of contraception throughout the study.
- Subjects likely to benefit from WHO step III opioid therapy for the duration of the study
- Subjects must not have received opioid containing medication in the last 6 months on a regular basis
- Receiving stable treatment for Parkinson's disease for at least 4 weeks prior to randomisation
- Subject does not have visual or auditory impairments that would reduce their ability to complete study questionnaires or be unable to receive instructions for these
- Concomitant medication (including co-analgesic) use anticipated to remain stable throughout the Double-Blind Phase of the study
- Subjects willing and able to participate in all aspects of the study and comply with the use of study medication.
- The aim of the Open-Label Phase is to ensure a safe transfer of all subjects to a subsequent pain treatment after the study. Subjects must:
- Have completed the Double-Blind Phase or discontinued early but have had at least 8 weeks treatment with study medication.
You may not qualify if:
- Subjects who are to be excluded from the study are those who meet any of the following criteria:
- Medical Conditions
- Cognitive impairment as assessed with the MMSE scoring 24 or less
- History of psychosis (hallucinations, delusions, etc.)
- History of drug or alcohol abuse or current compulsive addictive use of drugs or alcohol
- Parkinsonian-like disease secondary to drug therapy side-effects e.g. due to exposure to medications that deplete dopamine (reserpine, tetrabenazine) or block dopamine receptors (neuroleptics, antiemetics)
- Parkinson-plus syndromes e.g. progressive supranuclear palsy (PSP) and the multiple system atrophies (MSA)
- Females who are pregnant (positive β-hCG test) or lactating
- Any other contraindications to use of the opioid study medication(s) as per the SmPC/IB:
- Hypersensitivity to the active substances or to any of the excipients
- Any situation where opioids are contraindicated
- Severe respiratory depression with hypoxia and/or hypercapnia
- Severe chronic obstructive pulmonary disease
- Cor pulmonal
- Severe bronchial asthma
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Fakultní nemocnice u sv. Anny v Brně Neurologická klinika
Brno, Czechia
Poliklinika Choceň Neuroligická ambulance
Choceň, Czechia
Fakultní nemocnice Plzeň Neurologická klinika
Plzeň-Lochotín, Czechia
Neurologická ambulance
Polička, Czechia
CTC Rychnov nad Kněžnou s.r.o.
Rychnov nad Kněžnou, Czechia
Ruhr Universität Bochum St. Josef-Hospital
Bochum, Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Zentrum für Altersmedizin
Haag I. OB, Germany
Paracelsus-Elena-Klinik
Kassel, Germany
Uniklinik Leipzig
Leipzig, Germany
Philipps-Universität
Marburg, Germany
Asklepios Fachklinikum Abteilung für Neurologie
Stadtroda, Germany
Neurologie Berlin
Steglitz, Germany
Uniklinik Ulm
Ulm, Germany
Szent János Kórháza és Észak-budai Egyesített Kórházaik
Budapest, Hungary
Kenézy Kórház-Rendelőintézet Egészségügyi Szolgáltató Kft.
Debrecen, Hungary
Szent Pantaleon Kórház-Rendelőintézet Dunaújváros
Dunaújváros, Hungary
Vaszary Kolos Kórház Esztergom
Esztergom, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Hungary
Bács-Kiskun Megyei Kórháza
Kecskemét, Hungary
NZOZ Synapsa
Kielce, Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Poland
Spitalul Clinic de Neuropsihiatrie
Craiova, Jud. Dolj, Romania
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
USP Institut Universitari Dexeus
Barcelona, Spain
Hospital Universtario La Paz
Madrid, Spain
Hospital General de Catalunya
Sant Cugat, Barcelona, Spain
Fairfield General Hospital Pennine Acute NHS Trust
Bury Great Manchester, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
City General Hospital, Pharmacy Dept, Newcastle Road
Stoke-on-Trent, United Kingdom
Related Publications (1)
Trenkwalder C, Chaudhuri KR, Martinez-Martin P, Rascol O, Ehret R, Valis M, Satori M, Krygowska-Wajs A, Marti MJ, Reimer K, Oksche A, Lomax M, DeCesare J, Hopp M; PANDA study group. Prolonged-release oxycodone-naloxone for treatment of severe pain in patients with Parkinson's disease (PANDA): a double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2015 Dec;14(12):1161-70. doi: 10.1016/S1474-4422(15)00243-4. Epub 2015 Oct 19.
PMID: 26494524DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2011
First Posted
September 22, 2011
Study Start
October 1, 2011
Primary Completion
August 1, 2013
Study Completion
October 1, 2013
Last Updated
February 6, 2014
Record last verified: 2014-02