postoperative pain after knee arthroplasty MedDRA version: 12.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief MedDRA version: 12.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Trade Name: Targinact® 10/5 mg prolonged-release tablets
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hydrochloride
CAS Number: 124-90-3
Concentration unit: mg milligra
Sponsors
Mundipharma Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females equal or more than 18 – less than or equal 75 years of age. 2. Body mass index (BMI) equal or more than 18 – less than or equal 35 kg/m2. 3. If female and less than one year post-menopausal: – negative serum or urine pregnancy test (positive beta-human chorionic gonadotrophin test) at screening. – using an adequate and highly effective method of contraception throughout the study. A highly effective method of contraception is defined as one with a failure rate of less than 1% per year when used consistently and correctly. Examples include sterilisation, implants, injectables, combined oral contraceptives, hormonal intra uterine devices, sexual abstinence or vasectomised partner. 4. Confirmed diagnosis of osteoarthritis of the knee. 5. Planned surgical arthroplasty on one knee. 6. Planned postoperative epidural analgesia for approximately 48 hours. 7. Anticipated requirement for daily opioid treatment after epidural analgesia for 2.5 days. 8. Able to participate in the study and have given 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. Females who are pregnant or lactating. 2. Opioid use within 3 months before the start of the screening period. Stable treatment with analgesics in World Health Organisation (WHO) Step I (non-opioid analgesics) is allowed. 3. History of laxative use to treat constipation within 3 months before the start of the screening period. 4. History of chronic constipation. 5. Concurrent rheumatoid arthritis. 6. Planned bilateral arthroplasty or revision knee arthroplasty. 7. History of moderate to severe hepatic impairment. 8. History of moderate to severe respiratory depression with hypoxia or hypercapnia, chronic obstructive pulmonary disease, cor pulmonale, bronchial asthma, or any severe impairment of pulmonary function. 9. History of hypothyroidism, Addison’s disease (adrenal cortical insufficiency), psychosis, cholelithiasis, prostatic hypertrophy, delirium tremens, pancreatitis, hypotension, uncontrolled hypertension, uncontrolled cardiovascular diseases, head injury, epileptic disorder or predisposition to convulsions, or treatment with monoamine oxidase inhibitors (concurrent or within 2 weeks of discontinuation). 10. Contraindication to treatment with opioids. 11. History of hypersensitivity to oxycodone, naloxone, or to any of the excipients of OXN PR tablets. 12. History of non-opioid induced paralytic ileus. 13. Previous or current history of drug abuse, including alcohol abuse or opioid abuse. 14. Evidence of clinically unstable disease (determined by medical history, clinical laboratory tests, ECG, or physical examination) which, in the opinion of the Investigator, renders the subject unsuitable for the study. 15. Receipt of an investigational medicinal product within 30 days before the start of the screening period. 16. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 17. Delayed gastric emptying. 18. Severe renal impairment (i.e. creatinine clearance <10 mL/minute). 19. Weight <50 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate that treatment with OXN PR tablets is non-inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on average pain intensity scores at rest. Dosing will commence after the end of postoperative epidural analgesia. Subjects will rate their pain intensity on an 11-point numerical rating scale (NRS) of 0-10, twice a day, 1 hour after each dose of study medication for 5 doses (2.5 days).;Secondary Objective: • To evaluate the safety of OXN PR compared with OXY PR in terms of adverse events (AEs), physical examination, vital signs (supine blood pressure, heart rate and respiratory rate) and 12-lead electrocardiogram (ECG). • To compare the use of rescue analgesia between the OXN PR and OXY PR groups during the double-blind treatment phase. • To compare average dynamic pain intensities (11-point NRS) between the OXN PR and OXY PR groups during the double-blind treatment phase. • To compare current and worst pain intensities at rest and dynamic (11-point NRS) between the OXN PR and OXY PR groups during the double-blind treatment phase. Exploratory objectives: • To compare laxative intake between the OXN PR and OXY PR groups during the double-blind treatment phase. ;Primary end point(s): • The primary efficacy variable is the 24-hour pain intensity score at rest, on an NRS from 0-10, assessed 1 hour after dosing on Day 1, Day 2 and Day 3 (morning only). | — |
Countries
Finland
Outcome results
None listed