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Oxycodone/acetaminophen vs oxycodone hydrochloride sustained release tablets with paracetamol in patients with moderate cancer pain:A prospective, multicentre, randomized, controlled clinical study

Oxycodone/acetaminophen vs oxycodone hydrochloride sustained release tablets with paracetamol in patients with moderate cancer pain:A prospective, multicentre, randomized, controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090048
Enrollment
Unknown
Registered
2024-09-23
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Cancer pain

Interventions

Oxycodone/acetaminophen tables Group:analgesia with oxycodone/acetaminophen tables
Oxycodone hydrochloride sustained-release tablets Group:analgesia with oxycodone hydrochloride sustained-release tablets

Sponsors

Xiangyang No.1 People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The subject voluntarily signs the informed consent for this experiment; 2) Patients with histologically or pathologically diagnosed malignant solid tumors (excluding non-solid tumors such as hematologic tumors and lymphomas) 3) Age 18-80 years old (including 18 and 80 years old), clear awareness, regardless of the sex; 4) Opioid intolerant patients with cancer pain and 4=NRS score < 7 in the last 24 hours 5) ECOG-PS =3 points;

Exclusion criteria

Exclusion criteria: 1) The patient is diagnosed with non-cancerous pain or unexplained pain; 2) Patients with paralytic ileus; 3) Patients with severe neuropathic cancer pain and other refractory cancer pain; 4) Severe liver and kidney dysfunction, such as creatinine = 2 of the upper limit of normal ALT or AST= 2.5 times the upper limit of normal (liver metastases Or primary liver cancer = 5 times the upper limit of normal), or liver function Child C grade; 5) Cognitive dysfunction; 6) Patients allergic to narcotic drugs; 7) Pregnant or lactating patients;

Design outcomes

Primary

MeasureTime frame
Titration success rate;

Secondary

MeasureTime frame
NRS score 6h, 12h, 24h, 2d, 3d, 4d, 5d, 6d after the first treatment;Pain relief rate;Daily dose;Number of breakthrough pain;Satisfaction evaluation;quality of life;

Countries

China

Contacts

Public ContactYouhong Dong

Xiangyang No.1 People’s Hospital

dongyouhong2005@163.com+86 159 9730 5988

Outcome results

None listed

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