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A multicenter clinical randomized controlled single-blind study of hydromoradone sustained-release tablets and oxycodone hydrochloride sustained-release tablets in patients with advanced cancer pain

A multicenter clinical randomized controlled single-blind study of hydromoradone sustained-release tablets and oxycodone hydrochloride sustained-release tablets in patients with advanced cancer pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118932
Enrollment
Unknown
Registered
2026-02-12
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe cancer pain

Interventions

Hydromorphinone Hydrochloride sustained-release Tablet group:Hydromorphinone Hydrochloride sustained-release Tablet
Oxycodone Hydrochloride Sustained-release Tablets Group:oxycodone hydrochloride sustained-release tablet

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pain requirements: Moderate to severe chronic cancer pain caused by malignant tumors or their treatment (baseline 24-hour average pain intensity Digital scale (NRS) >=4 points). 2. History of opioid use: No strong opioid drugs have been used, or weak opioids (such as codeine, tramadol) or low-dose strong opioid drugs (such as morphine ready-to-release tablets = 3 months.

Exclusion criteria

Exclusion criteria: 1. Allergy to the study drug or its components; severe liver or kidney dysfunction (specific indicators need to be clarified); 2. Severe respiratory depression or acute exacerbation of chronic obstructive pulmonary disease; 3. Uncontrolled epilepsy; increased intracranial pressure; 4. Concurrent use of monoamine oxidase inhibitors; 5. Presence of cognitive or psychiatric disorders that may interfere with pain assessment or study compliance; 6. Pregnant or breastfeeding women; 7. Other conditions deemed by the investigator as unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
The change in the average daily maximum severe pain intensity (NRS) from baseline at the 4th week of treatment;

Secondary

MeasureTime frame
Incidence of adverse reactions;living quality;The changes of NRS at each time point within 12 weeks;

Countries

China

Contacts

Public ContactXiaoPeng Mei

The First Affiliated Hospital of Xi'an Jiaotong University

meixpxp@126.com+86 29 8532 4757

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026