Severe pain due to diabetic polyneuropathy MedDRA version: 9.1 Level: LLT Classification code 10012685 Term: Diabetic polyneuropathy
Conditions
Interventions
Product Name: Oxycodone/naloxone prolonged-release tablets 5/2.5 mg
Product Code: OXN PR 5/2.5 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hydrochloride
CAS Number:
Sponsors
Mundipharma Research GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects at least 18 years (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is 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). 2. Subjects with type 1 (IDDM) or type 2 (NIDDM) diabetes. 3. Subjects with severe pain due to diabetic/idiopathic polyneuropathy, confirmed by a score of = 5 for their average pain over last 24 hrs and by a MNSI assessment score of = 2.5 at the Screening Visit that requires additional opioid therapy (20 - 80 mg OXN PR per day) for a minimum of 12 weeks. 4. Subjects established on a maximum tolerated dose of pregabalin for at least 1 month but who are still experiencing severe pain. 5. Subjects, who are receiving pregabalin up to a maximum daily dose of 600 mg as a compulsory treatment for the treatment of their neuropathic pain due to diabetic/idiopathic polyneuropathy. 6. Subject’s whose pregabalin dose is 8 up to 11% maybe eligible if, in the opinion of the investigator, attempts have been made by the subject to improve diabetic control but these attempts have failed. Criteria for entry to the Double-blind phase: 1. Subjects continue to satisfy screening inclusion/exclusion criteria. 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, paracetamol, bisacodyl, pregabalin and related products or other ingredients of the provided medication. 2. Any contraindication to oxycodone, naloxone, paracetamol, bisacodyl and other ingredients of the provided medication. 3. Active alcohol or drug abuse and/or history of opioid abuse. 4. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease, 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 or that may confound the analysis and/or interpretation of the study results. 5. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (> 3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range), gamma glutamyl transpeptidase (GGT or GGTP) = 5 times the upper limit of normal. 6. 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. 7. Subjects with uncontrolled seizures or convulsive disorder. 8. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period). 9. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week double-blind phase that may affect GI motility or pain. 10. Subjects presently taking, or who have taken, naloxone less than or equal 30 days prior to the start of the Screening Period. 11. Subjects suffering from diarrhoea. 12. Subjects with any situation in which opioids are contraindicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, paralytic ileus. 13. Subjects with myxoedema, hypothyroidism, Addison`s disease, increase of intracranial pressure. 14. Previous treatment with oxycodone in combination with pregabalin. 15. Patients with any co-existing condition that may produce pain independently of the neuropathic pain under study, and in the Investigator’s opinion may confound assessment of the patient’s neuropathic pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show superior analgesic efficacy of OXN PR in addition to a patient’s current dose of pregabalin compared to pregabalin alone based on the “Short-Form McGill Pain Questionnaire” assessed at each visit. (Melzack, 1987). ;Secondary Objective: • To assess the frequency of pain rescue medication intake. • To assess the “average Pain over the last 24 hrs” as assessed at each visit (NRS 0 – 10). • To determine that the bowel function of patients receiving OXN PR is comparable to the bowel function of patients receiving pregabalin alone based on the Bowel Function Index (BFI) assessed at each study visit. • To assess severity and interference of pain based on the modified Brief Pain Inventory, Short Form (BPI-SF) (Cleeland & Ryan, 1994). • To assess the laxative medication (bisacodyl) intake. • To assess the stool consistency during the 12 week treatment period based on the Bristol Stool Form Scale (BSFS). • To assess overall health based on the SF-36 v2. • To assess quality of life based on EuroQol EQ-5D (Brook, 1996).;Primary end point(s): • The Short-Form McGill Pain Questionnaire, also known as Short-Form McGill pain index, is a scale of rating pain developed at McGill University by Melzack and Torgerson in 1971. The Short-Form McGill Pain Questionnaire consists primarily of three major classes of word descriptors - sensory, affective and evaluative - that are used by patients to specify subjective pain experience. It also contains an intensity scale and other items to determine the properties of pain experience. The questionnaire was designed to provide quantitative measures of clinical pain that can be treated statistically. The three major measures are: (1) the pain rating index, based on two types of numerical values that can be assigned to each word descriptor; (2) the number of words chosen; and (3) the present pain intensity based on a 1-5 intensity scale. | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed