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Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain

ConditionsOpioid-Induced ConstipationPain Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets

    Drug

    1. Calculate the total opioid dosage administered to the patient in the previous 24 hours and convert it to an equivalent dose of oxycodone/naloxone sustained-release tablets(Mimeixin). 2. Based on the principle of incremental dosing, calculate the total dosage to be administered on the day of enrollment, divide it into two portions, and administer one portion every 12 hours (q12h). 3. In case of breakthrough pain during treatment, administer an equivalent dose of immediate-release morphine or other medications equivalent to 10%-20% of the 24-hour background dosing for relief. 4. If the number of breakthrough pain events exceeds 2 in a day after dosing, adjust the dosage again based on the incremental dosing principle. Adjustments should be made every 1-2 days, with each adjustment increasing the dose by a gradient of 5 mg/2.5 mg or 10 mg/5 mg of oxycodone/naloxone sustained-release tablets, twice daily, and so on. The maximum daily dose of oxycodone should not exceed 160 mg.

Treatment groups

203 Participants
are divided into 1 treatment group
Group A: Oxycodone/naloxone sustained-release tablets treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes of Patients' Bowel Function of day 28

The BFI score was used for evaluation, and the data were repeatedly measured. A one-way repeated measures ANOVA model was used, which included follow-up time and baseline BFI values; the variation curve of BFI with follow-up time was also plotted. The analytical method for repeatedly measured data of secondary endpoints was consistent with the primary analytical method.

Time frame
pre-intervention, day 7, day 14, day 21 and day 28 after the intervention

Secondary outcomes

1

Changes of Cancer Pain with NRS

Assess and record pain experienced within 24 hours using the Numerical Rating Scale (NRS) The numerical rating scale (NRS) uses 0-10 to represent different levels of pain, with higher scores indicating higher levels of pain.

Time frame
through study completion, an average of 4 weeks
2

Changes of Cancer Pain with BPI-SF

Assess and record pain experienced concurrently with the Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess the degree of pain effect in the past 24 hours on a scale of 0-10, with 0 as no effect and 10 as complete effect.

Time frame
through study completion, an average of 4 weeks
3

Changes of breakthrough pain

Documented the frequency of breakthrough pain within 24 hours, as well as the types and amounts of rescue medications used within 24 hours.

Time frame
within 24 hours
4

Frequency of bowel movements and CSBMs

Documented the number of bowel movements and CSBMs.CSBM is defined as a spontaneous bowel movement accompanied by a complete sense of emptying, without the use of rescue laxatives or manual assistance.

Time frame
through study completion, an average of 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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