Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital
About this trial
This study is a prospective, single-arm, multicenter, real-world study to evaluate effect of bowel function, analgesic effect, quality of life, and safety of Mimeixin® in Chinese patients with severe cancer pain.
Eligibility criteria
Qualifiers
Age ≥ 18 years old, with a histological or pathological diagnosis of advanced cancer.
Be diagnosed with severe (NRS ≥ 7 points) cancer pain, requiring regular opioid therapy.
Diagnosed with OIC according to the Rome IV diagnostic criteria for OIC, with a BFI score ≥ 30.
Determined by the investigator to be eligible for treatment with oxycodone/naloxone sustained-release tablets.
Disqualifiers
Patients with contraindications to oxycodone/naloxone sustained-release tablets (including allergy to the active ingredients or any excipients of this product; severe respiratory depression accompanied by hypoxemia and/or hypercapnia; severe chronic obstructive pulmonary disease; pulmonary heart disease; severe bronchial asthma; paralytic ileus caused by non-opioid drugs; moderate to severe liver function impairment).
Patients with structural malformations of the gastrointestinal tract (such as intestinal obstruction, stenosis), other known gastrointestinal diseases/symptoms (including cancer metastasis to the digestive tract), or gastrointestinal digestion and absorption disorders.
Patients with language communication barriers, cognitive impairments or mental illnesses, intracranial metastasis of tumors with consciousness disorders, or consciousness disorders caused by other reasons.
Other situations that the investigator judges as unsuitable for inclusion in the study.
Trial design
Treatments tested in this trial
- Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets
Treatment groups
203 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov