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Application of OROS® Hydromorphone in cancer pain patients with poor analgesic effect of oxycodone hydrochloride sustained-release tablets

Application of Hydromorphone Hydrochloride Extended-release Tablets in Cancer Pain Patients with Poor Analgesic Effect of Oxycodone Hydrochloride Sustained-Release Tablets:A Randomized, Single-blind Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115160
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Cancer pain

Interventions

Morphine ER Group:Equivalent rotation of oxycodone with Morphine Sulfate Extended-release Tablets
Hydromorphone group:Equivalent rotation of oxycodone with OROS Hydromorphone

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.aged >=18 years; 2.patients with cancer pain; 3.Oxycodone hydrochloride sustained-release tablets are used for the management of cancer-related pain; 4.Inadequate control of cancer pain with a daily resting Numeric Rating Scale (NRS) score persistently >= 4, and the occurrence of more than three episodes of breakthrough pain

Exclusion criteria

Exclusion criteria: 1.Severe respiratory compromise or severely depressed ventilatory function, impaired renal, cardiac or hepatic function,; 2.Use of monoamine oxidase inhibitors within 2 weeks prior to study entry; 3.Presence of conditions for which risks of opioid use outweigh potential benefits (e.g., raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders, Addison's disease); 4.Current or recent (within 6 months) history of drug and/or alcohol abuse; 5.Pure neuropathic pain or pain of unknown causes

Design outcomes

Primary

MeasureTime frame
Time (in days) required to titrate the dosages of the two drugs to achieve adequate analgesic effect;

Secondary

MeasureTime frame
The occurrence of adverse drug reactions (nausea, vomiting, drowsiness, constipation);The most severe pain score in the past 24 hours (patients self-assessment through a questionnaire-based brief pain inventory, BPI);The current impact of cancer pain on daily life;

Countries

China

Contacts

Public ContactJiao Zhang

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

jzhang0127@163.com+86 10 69152020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026