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A Phase # Clinical Study Trial of Felbinac Trometamol Injection in China

NCT05297669 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-05-22

No results posted yet for this study

Summary

A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of postoperative pain in gynecology.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery

Conditions

Interventions

DRUG

Felbinac Trometamol Injection

Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).. One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.

DRUG

Placebos

Placebo diluted to 100 ml with 0.9% sodium chloride injection. Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min). One dose at 8h and 16h after the start of the first dose, the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.

Sponsors & Collaborators

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Mengchang Gao, MD · Sichuan Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2022-01-19
Completion
2022-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297669 on ClinicalTrials.gov