Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency
Not yet recruitingNCT07421674
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency. It will also understand key safety concerns, especially regarding renal function and neurotoxicity. The main questions it aims to answer include:1. Can hydromorphinone sustained-release tablets effectively relieve the pain of such patients and improve their quality of life?2. During the treatment period, what effect does this drug have on renal function (measured by eGFR)? 3. In this specific population, what are the occurrence and characteristics of neurotoxicity and other side effects induced by opioids? Researchers will compare elderly cancer pain patients with renal insufficiency with those with normal renal function (both receiving the study drug treatment) to observe whether there are differences in efficacy and safety results. Participants will: Receive a standardized treatment plan: First, subcutaneous injection of hydromorphinone injection for dose titration, and then switch to daily oral administration of hydromorphinone sustained-release tablets for 4 weeks. Visit the clinic for assessment and examination (including renal function tests) during the baseline period, on the 7th day, and at the weekends of the 2nd, 3rd, and 4th days. Regularly monitor and record the degree of pain, the occurrence of explosive pain, the use of medication, and any side effects.
Study details
- Official title
- Application Research of Hydromorphinone Sustained-release Tablets in the Treatment of Elderly Patients With Cancer Pain Accompanied by Renal Insufficiency
- Conditions
- Cancer Pain
- Renal Insufficiency Chronic
- Hydromorphone Use
- Sponsor
- Taian Cancer Hospital
- Start date
- 2026-02-10
- Primary completion
- 2028-12-31
- Sex
- All
- Age range
- from 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age ≥ 65 years. 2. Pathologically or cytologically confirmed malignant tumor. 3. Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4). 4. Renal function meeting one of the following criteria at baseline: 1）Mild-to-moderate renal insufficiency group: 30 mL/min/1.73m² ≤ estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m². 2）Normal renal function group: eGFR ≥ 90 mL/min/1.73m². 5.Expected survival period ≥ 3 months. 6.Ability to take oral medication and cooperate with study assessments. 7.Willing to participate voluntarily and able to provide signed informed consent. Exclusion Criteria: 1. Severe renal insufficiency (eGFR \< 30 mL/min/1.73m²) or requirement for renal replacement therapy. 2. Severe hepatic insufficiency (alanine aminotransferase / aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C). 3. Paralytic ileus. 4. Pain of unclear origin or pain that is solely acute/incident pain. 5. Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders. 6. Symptoms of prostatic hypertrophy, thyroid dysfunction, or urethral stricture. Symptoms of asthma, respiratory obstruction, or respiratory failure. 7. Known allergy or hypersensitivity to hydromorphone or oxycodone. 8. Use of monoamine oxidase inhibitors within 14 days prior to enrollment. 9. Participation in any other clinical trial within 1 month prior to enrollment. 10. Any other condition considered by the investigator as unsuitable for participation in this study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07421674