Male and female patients who are designated for a total hip endoprosthesis MedDRA version: 7.1 Level: low Classification code 10044088
Conditions
Interventions
Trade Name: Oxygesic 5 mg
Product Name: Oxygesic 5 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone Hydrochloride
CAS Number: 124-90-3
Concentration unit: mg milligram(s
Sponsors
Mundipharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients (males and females) designated for total hip endoprosthesis. Males and females aged 18 years and older (females less than one year post-menopausal must have a negative serum pregnancy test, be non-lactating and willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control with a failure rate less than 1% per year are such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.). •Patients have to understand protocol requirements and are willing and able to fulfill them. •Patients must be able to understand the patient information sheet (PIS) and have provided written informed consent of study participation and concerning data protection. •Patients have to be willing and able to complete questionnaires. 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: •Other opioid treatment beside study medication. •Clinically significant respiratory disease, cardiac disease, dysfunction of the biliary tract, thy-roid disease, adrenal cortical insufficiency, prostatic hypertrophy or renal stricture or any other medical condition, that, in the opinion of the investigator, precludes entry into this study. •Laboratory findings of impaired liver function (i.e. nlt 3 x ULN for AST or ALT or increasing AST/ALT as indication of liver impairment), or, in the opinion of the investigator, liver function impairment to the extent that the patient should not participate in this study. •Indication of impaired kidney function (i.e. nlt 1,5 x ULN for serum creatinine). •Depression or other psychiatric disorder such that participation in the study may, in the opin-ion of the investigator, pose an unacceptable risk to the patient. •Seizures or convulsive disorder requiring concomitant anticonvulsant therapy. •Known hypersensitivity (allergic reaction) to oxycodone hydrochloride or diclofenac colestyramine. •Patients with porphyria. •Patients with gastro-intestinal ulceration. •Patients with dyshaematopoiesis of unknown origin. •Patients with systemic lupus erythematosus. •Patients suffering from Morbus Parkinson. •Patients with history of paralytic ileus. •Patients with current acute pancreatitis. •Past or current substance or alcohol abuse, or patients who, in the opinion of the investigator, have demonstrated addictive or substance abuse behaviors. •Patients who have participated in another clinical trial within 12 weeks before start of this trial or who currently participate in one.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate whether the analgesia of Oxycodone Hydrochloride CR tablets administered orally and Oxycodone Hydrochloride Injection Solution administered intravenously in combination with an oral premedication of Oxycodone Hydrochloride CR tablets is superior in comparison to Oxycodone Hydrochloride CR tablets administered orally and Oxycodone Hydrochloride Injection Solution administered intravenously without an oral premedication of Oxycodone Hydrochloride CR tablets. Both treatment groups (premedication / no premedication) receive additionally diclofenac colestyramine CR capsules. Differences between both treatment groups will be investigated by the need for analgesics in general and the relative frequency of dose increase respectively.;Secondary Objective: Secondary objectives are to determine data concerning safety and tolerability, quality of life, hospi-talization time and degree of mobility as well as to assess differences between both treatment groups.;Primary end point(s): The primary efficacy variable is the relative number of patients with dose increase in both treatment groups. | — |
Countries
Germany
Outcome results
None listed