moderate to severe pain non-malignant pain MedDRA version: 9.1 Level: LLT Classification code 10033371 Term: Pain
Conditions
Interventions
Product Name: oxycodone/naloxone
Product Code: OXN 40/20
Pharmaceutical Form: Tablet
INN or Proposed INN: oxycodone hydrochloride
CAS Number: 124-90-3
Other descriptive name: 4,5-alpha-epoxy-14-hydrox
Sponsors
Mundipharma Pharmaceuticals BV
Mundipharma Comm VA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients at least 18 years or older with moderate to severe non-malignant pain who are willing to provide written informed consent. 2.Females less than one year post-menopausal must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner. 3.Patients with documented history of moderate to severe, non-malignant pain treated with WHO step I or II analgesics with insufficient pain relief and/or unacceptable side effects that requires around-the-clock opioid therapy (starting dose of oxycodone over 20- mg/day) and are likely to benefit from WHO step III opioid therapy for the duration of the study. Patients must be willing to discontinue their current opioid analgesic routine. 4.Patients are willing to discontinue pre study laxative medication. 5.Patients taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose and regimen throughout the study, and in the investigators opinion are willing and able to maintain adequate hydration. 6.Patients willing and able to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Any history of hypersensitivity to oxycodone, naloxone, related products, and other ingredients. 2.Patients that require a dose over 20 mg/day oxycodone at the start of the study.. 3.Active alcohol or drug abuse and/or history of opioid abuse. 4.Evidence of clinically significant cardiovascular, renal, hepatic, ,or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results. 5.In the investigator’s opinion, patients who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication. 6.Patients receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine). 7.Patients with uncontrolled seizures or convulsive disorder. 8.Patients who have a confirmed diagnosis of ongoing irritable bowel syndrome. 9.Patients with evidence of clinically significant gastrointestinal disease (e.g. paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g. scarring, obstruction etc). 10.Patients who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry. 11.Surgery completed prior to the start of the study, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study. 12.Patients presently taking, or who have taken, naloxone ?30 days prior to the start of the study. 13.Patients suffering from diarrhoea and/or opioid withdrawal. 14.Patients with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus. 15.Patients with myxodema, hypothyroidism, Addisons disease, increase of intracranial pressure and/or epilepsy (see also exclusion criteria 7.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the patient preference of OXN treatment compared to previous WHO step I or II analgesics with respect to quality of life (5 categories).;Secondary Objective: •To evaluate patient preference of OXN compared to previous WHO step I or II analgesics with respect to overal treatment (5 categories). •To assess symptoms of constipation (Bowel Function Index (BFI), 2 questions and laxative use) •To evaluate pain relief (NAS, 0-100 mm) •To assess safety of OXN treatment •To assess the Quality of Life ( EuroQuol EQ-5 day questionnaire);Primary end point(s): The patient preference of OXN compared to previous WHO step I or II analgesic therapy with respect to quality of life, at any time during the 3 weeks treatment phase, as measured on a 5 points ordinal scale. For the analysis the ordinal scale will be reduced to a binary scale: responder or no responder. A responder is defined as a patient responding with better or much better at any time during the OXN therapy. | — |
Countries
Belgium
Outcome results
None listed