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Parkinson's Disease With Severe PainPhase 3NCT01439100

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

A Phase 3 study testing Oxycodone/Naloxone Prolonged Release tablets in people with Parkinson's Disease With Severe Pain, run by Mundipharma Research GmbH & Co KG at 31 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Parkinson's Disease With Severe Pain
What is being tested?
Oxycodone/Naloxone Prolonged Release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
31 sitesin 7 countries
Study dates
Oct 2011to Oct 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.
  • Open-Label Extension Inclusion Criteria
  • 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:
  • Still meet general inclusion criteria for Double-Blind Phase; subjects do not have to meet inclusion 5, 6, 9 \& 12
  • Have completed the Double-Blind Phase or discontinued early but have had at least 8 weeks treatment with study medication.

Who cannot join

  • 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)
Show all 41Show fewer
  • 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
  • Non-opioid induced paralytic ileus
  • Moderate to severe hepatic impairment (see exclusion criterion 16)
  • Any other contraindications to use of the study Double-Blind Phase rescue medication as per the SmPC:
  • known hypersensitivity to levodopa or benserazide
  • contra-indicated in narrow-angle glaucoma (it may be used in wide-angle glaucoma provided that the intra-ocular pressure remains under control); severe psychoneuroses or psychoses; severe endocrine, renal, hepatic or cardiac disorders
  • should not be given in conjunction with, or within 2 weeks of withdrawal of, monoamine oxidase (MAO) inhibitors, except selective MAO-B inhibitors (e.g. selegiline) or selective MAO-A inhibitors (e.g. moclobemide) unless selective MAO inhibitors are given in combination in which case it is contraindicated
  • not be used in persons who have a history of, or who may be suffering from, a malignant melanoma
  • Subjects with any of the following as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication:
  • myxoedema
  • untreated hypothyroidism
  • Addison's disease
  • increase of intracranial pressure
  • uncontrolled seizures or convulsive disorder
  • evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease (subjects with controlled co-morbidities may be included following agreement with the Medical Monitor) Contraindicated Treatments
  • Treatment with Deep Brain Stimulation
  • Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
  • Subjects presently taking, or who have taken, naloxone or naltrexone less than or equal to 30 days prior to the Screening Visit
  • Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Phase)
  • Any current use of an opioid other than the study medication provided
  • Subjects with a positive urine drug test at Screening Visit 1, which indicates unreported illicit drug use or unreported use of a concomitant medication not required to treat the Subjects' medical condition(s) Laboratory Exclusions
  • Abnormal parameters as defined:
  • aspartate aminotransferase (AST; SGOT) > 3 times the upper limit of normal
  • alanine aminotransferase (ALT; SGPT) > 3 times the upper limit of normal
  • alkaline phosphatase levels > 3 times the upper limit of normal
  • gamma glutamyl transpeptidase (GGT or GGTP) > 3 times the upper limit of normal
  • Abnormal total bilirubin and/or creatinine level(s) > 1.5 times the upper limit of normal. Subjects whose total bilirubin levels or creatinine levels are below the lower limit of normal can participate in the study if they meet the criteria below:

Trial locations and contacts

31 sites in 7 countries.

31 sites in 7 countries

Germany9 sites

  • Ruhr Universität Bochum St. Josef-Hospital

    Bochum

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen

  • Zentrum für Altersmedizin

    Haag I. OB

  • Paracelsus-Elena-Klinik

    Kassel

  • Uniklinik Leipzig

    Leipzig

  • Philipps-Universität

    Marburg

  • Asklepios Fachklinikum Abteilung für Neurologie

    Stadtroda

  • Neurologie Berlin

    Steglitz

  • Uniklinik Ulm

    Ulm

Other trials in Germany

Hungary6 sites

  • Szent János Kórháza és Észak-budai Egyesített Kórházaik

    Budapest

  • Kenézy Kórház-Rendelőintézet Egészségügyi Szolgáltató Kft.

    Debrecen

  • Szent Pantaleon Kórház-Rendelőintézet Dunaújváros

    Dunaújváros

  • Vaszary Kolos Kórház Esztergom

    Esztergom

  • Petz Aladár Megyei Oktató Kórház

    Győr

  • Bács-Kiskun Megyei Kórháza

    Kecskemét

Other trials in Hungary

Czechia5 sites

  • Fakultní nemocnice u sv. Anny v Brně Neurologická klinika

    Brno

  • Poliklinika Choceň Neuroligická ambulance

    Choceň

  • Fakultní nemocnice Plzeň Neurologická klinika

    Plzeň-Lochotín

  • Neurologická ambulance

    Polička

  • CTC Rychnov nad Kněžnou s.r.o.

    Rychnov nad Kněžnou

Other trials in Czechia

Spain4 sites

  • Hospital Clínic i Provincial de Barcelona

    Barcelona

  • USP Institut Universitari Dexeus

    Barcelona

  • Hospital Universtario La Paz

    Madrid

  • Hospital General de Catalunya

    Sant Cugat, Barcelona

Other trials in Spain

United Kingdom4 sites

  • Fairfield General Hospital Pennine Acute NHS Trust

    Bury Great Manchester

  • King's College Hospital NHS Foundation Trust

    London

  • Royal Preston Hospital

    Preston

  • City General Hospital, Pharmacy Dept, Newcastle Road

    Stoke-on-Trent

Other trials in United Kingdom

Poland2 sites

  • NZOZ Synapsa

    Kielce

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow

Other trials in Poland

Romania1 site

  • Spitalul Clinic de Neuropsihiatrie

    Craiova, Jud. Dolj

Other trials in Romania

About this study

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

Read the 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.

Being tested
Oxycodone/Naloxone Prolonged Release tablets, Placebo
Keywords
Parkinson's disease, severe pain, OXN PR, randomised
Medical subject headings
Parkinson Disease, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone/Naloxone Prolonged Release tabletsDrug

  • PlaceboDrug

    Dummy tablet

Study groups in NCT01439100
Study groupRoleWhat they receive
OXN PRActive comparatorOxycodone/Naloxone Prolonged Release tablets
Receives: Drug: Oxycodone/Naloxone Prolonged Release tablets
Dummy tabletPlacebo comparatorPlacebo
Receives: Drug: Placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionAug 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01439100
Sponsor's protocol ID
OXN2504
Other IDs
2011-002901-31
Status last verified
Feb 2014
First submitted
21 Sep 2011
Last updated
6 Feb 2014
Results posted
No

Publications

  • 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.

    PubMed 26494524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxycodone/Naloxone Prolonged Release tablets in people with Parkinson's Disease With Severe Pain, run by Mundipharma Research GmbH & Co KG at 31 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany, Hungary, Czechia, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01439100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.

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