Opioid-Induced ConstipationPhase 4NCT06897917
Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
A Phase 4 study testing Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets in people with Opioid-Induced Constipation and Pain Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Induced Constipation, Pain Cancer
- What is being tested?
- Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Dec 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Estimated survival period of more than 3 months.
- Voluntarily sign an informed consent form.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Henan Cancer Hospital
Zhengzhou, Henan
Suxia Luo, Doctor, 8618638553211, luosxrm@163.com
About this study
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.
Read the detailed description
Cancer remains a significant health concern globally, with rising incidence and mortality rates. In 2022, there were 19.96 million new cancer cases and 9.74 million cancer deaths worldwide, including 4.8 million new cases and 2.6 million deaths in China. Cancer patients often experience pain during treatment, with 40% of patients reporting persistent pain, particularly moderate to severe pain, occurring in 40%-80% of cases. Unrelieved pain can exacerbate symptoms such as anxiety, depression, fatigue, insomnia, and loss of appetite, significantly impacting patients' quality of life. Opioids, represented by morphine and oxycodone, are widely used for the treatment of moderate to severe cancer pain.
Long-term opioid use often leads to gastrointestinal adverse events, with opioid-induced constipation (OIC) being the most common, significantly affecting patients' quality of life and treatment compliance. Although some guidelines recommend laxatives as prophylactic and first-line treatment for OIC, approximately half of the patients do not experience adequate symptom improvement. The mechanism of OIC primarily involves the activation of intestinal μ-opioid receptors, which is difficult to address solely with laxatives. The key to treating OIC lies in blocking the stimulation of μ-opioid receptors in the gastrointestinal tract while maintaining the analgesic effect of opioid receptors in the central nervous system.
Oxycodone/naloxone sustained-release tablets, a combination of the opioid receptor agonist oxycodone and the antagonist naloxone, effectively provide analgesia while improving OIC. Foreign studies have demonstrated that this medication significantly improves OIC while maintaining good analgesic effects, with good long-term tolerability. Mimeixin® is an oxycodone/naloxone sustained-release tablet developed with reference to the foreign-listed drug Targin®. It was approved by the National Medical Products Administration of China in June 2024 for the treatment of severe pain in adults that requires opioid analgesics for adequate control. However, clinical validation has not been conducted among Chinese cancer pain patients. Therefore, a prospective, single-arm, multicenter, real-world study is planned to evaluate the effect in bowel function, analgesic effect, quality of life, and safety of Mimeixin® in Chinese patients with severe cancer pain in real-world clinical practice.
- Conditions
- Opioid-Induced Constipation, Pain Cancer
- Being tested
- Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets
- Keywords
- opioid-induced constipation, severe cancer pain, Oxycodone/naloxone sustained-release tablets
- Medical subject headings
- Opioid-Induced Constipation, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release TabletsDrug
Also called Mimeixin
- 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).
- 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).
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone/naloxone sustained-release tablets treatment group | Experimental | Patients receiving oxycodone naloxone sustained-release tablets were included in the study cohort. Receives: Drug: Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention, day 7, day 14, day 21 and day 28 after the intervention
Secondary outcomes (10)
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.
Measured: through study completion, an average of 4 weeks
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.
Measured: through study completion, an average of 4 weeks
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.
Measured: within 24 hours
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.
Measured: through study completion, an average of 4 weeks
Laxative Use
Record the type and amount of laxatives used.
Measured: through study completion, an average of 4 weeks
Assessment of withdrawal symptoms
Recorded using Subjective Opioid Withdrawal Scale (SOWS).
Measured: pre-intervention, day 2 and day 28 after the intervention
Changes of Quality of Life with EQ-5D-5L
The EQ-5D-5L consists of two main components: the EQ-5D Descriptive System and the EQ-5D Visual Analogue Scale (VAS). A score of 1-5 and a score of 0-100 were used to describe health status, with higher EQ-5D Descriptive System scores indicating worse health status and higher EQ-5D VAS scores indicating better health status.
Measured: day 7, day 14, day 21 and day 28 after the intervention
Changes of Quality of Life with SF-6D
The SF-6D describes health status on a scale of 0-5. The best health status was "111111", and the worst health status was "555655".
Measured: day 7, day 14, day 21 and day 28 after the intervention
Changes of Quality of Life with PAC-QOL
The PAC-QOL assesses the impact of constipation on your daily life over the past 2 weeks. It consists of 28 questions, each scored from 0 to 4.
Measured: day 7, day 14, day 21 and day 28 after the intervention
Incidence of adverse events (Safety Evaluation)
The grading criteria for adverse events follow the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0) of the National Cancer Institute (NCI).
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Induced ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, Doctor, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897917
- Sponsor's protocol ID
- MMX-RWS-01
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No