Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT02516059
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old
* Informed Consent as documented by signature
* Renal function: eGFR \>40ml/min
* Normal liver function
* Cystectomy with urinary diversion
* Use of thoracic epidural analgesia
Exclusion Criteria
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, i.e. known allergy to oxycodone naloxone or other excipients
* Women who are pregnant or breast feeding, (exclusion for surgery per se)
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, severe psychiatric disorder, etc. of the participant
* Severe asthma bronchiale, severe COPD
* Severe respiratory depression with hypoxia and/or hypercapnoea, cor pulmonale
* Preoperative use of MAO-Inhibitors (or has to be stopped 2 weeks before surgery)
* Patients with chronic pain
* Patients with regular use of antiemetics, laxatives, opioids or other types of analgesics
* Preoperative regular use of non steroidal anti inflammatory drugs and steroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02516059
Study Brief:
Protocol Section:
NCT02516059