A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Study, to Evaluate the Efficacy and Safety of Dinalbuphine Sebacate Extended Release Injection in Patients With Postoperation Pain

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Study, to Evaluate the Efficacy and Safety of Dinalbuphine Sebacate Extended Release Injection Compare with Placebo in Patients With Postoperation Pain After Laparotomy Operation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045554

Enrollment

Unknown

Registered

2021-04-19

Start date

2021-05-31

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Postoperation pain

Interventions

Experimental group:Intramuscular Injection of Dinalbuphine Sebacate Extended Release Injection

Control group:Intramuscular Injection of Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily signed informed consent; 2. Male or female aged between 18 and 70 (including 18 and 70); 3. Body mass index (BMI) 18-30kg/m2; 4. Patients who underwent open abdominal surgery under general anesthesia and expected moderate or severe postoperative pain; 5. Have the ability to communicate with the medical staff and comply with the relevant regulations of the hospital; 6. Willing and able to comply with the requirements of this test.

Exclusion criteria

Exclusion criteria: 1. People who have a history of opioid allergy, or who are expected to be allergic to or have contraindications to drugs that may be used during the trial; 2. Patients who are expected to need analgesic treatment due to other diseases or other procedures during the study period; 3. Use opioids for at least 14 days within 3 months prior to signing the informed consent; 4. Patients who are expected to suffer from life-threatening complications after surgery; 5. The presence of any mental or neurological disease or disorder that would interfere with study evaluation or compliance; 6. People with a history of alcohol abuse, drug abuse or drug dependence; 7. Pregnancy period and lactation period; 8. Other circumstances that the investigator considers inappropriate for participation in this study.

Design outcomes

Primary

Measure	Time frame
Total amount of morphine used within 48 hours after surgery;	—

Secondary

Measure	Time frame
Total amount of remedial analgesics from 48 hours to D7 after surgery;Area under the visual analogue scale (VAS) curve of pain severity within 48 hours after surgery;	—

Countries

China

Contacts

Public ContactZhang Ying

Shanghai Jemincare Pharmaceuticals Co., Ltd

zhangying@jemincare.com+86 21 58306003

Outcome results

None listed

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