2025-524431-39-00招募中3 期
An open label, pharmacokinetic and safety study of Combogesic® IV in pediatric patients with acute pain.
Aft Pharmaceuticals Limited5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- The incidence of treatment-emergent adverse events associated with exposure to Combogesic® IV.
研究概览
简要总结
Determine the safety and pharmacokinetics of Combogesic® IV in children and adolescents between the ages of 2 and <17 years.
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Is male or female aged between 2 and <17 years.
- •Have a clinical indication of acute pain requiring hospitalization and multiple doses of parenterally administered nonopioid analgesic medication for at least 0.5 - 5 days.
- •Is either able to provide written informed consent or consent is provided from parents/legal guardians and assent provided from participants (where appropriate).
- •Is willing and able to remain at the study site for at least 12 hours and to attend a follow-up visit at 7 ± 2 days after the last dose of study drug.
- •Have negative HIV and hepatitis B & C test results.
排除标准
- •Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required.
- •Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before screening (inhaled nasal steroids and regional/limited area application of topical corticosteroids (Investigator discretion) are allowed).
- •Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for ≥ 30 days before screening and has not experienced any relevant medical problem.
- •Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥ 3 times the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or creatinine ≥ 1.5 times the ULN).
- •Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.
- •Participated in another clinical study within 30 days before Screening.
- •Pregnant or lactating females
- •Sexually active females of childbearing potential not using adequate contraception** and sexually active males not using adequate contraception
- •Has experienced any surgical complications or other issues that, in the opinion of the Investigator, could compromise the safety of the subject if he or she participates in the study or could confound the results of the study.
- •Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the Investigator, could compromise the subject’s welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
- •Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the Investigator, would affect the subject’s ability to comply with the study requirements.
- •Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI) event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding.
- •Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance.
- •Is considered by the Investigator, for any reason to be an unsuitable candidate to receive the study drug.
- •Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding treated squamous or basal cell carcinoma of the skin).
- •Is currently receiving anticoagulants (e.g. heparin or warfarin).
研究组 & 干预措施
Paracetamol/Ibuprofen Vale 1000 mg/300 mg oldatos infúzió
Test
干预措施: Paracetamol/Ibuprofen Vale 1000 mg/300 mg oldatos infúzió (Drug)
结局指标
主要结局
The incidence of treatment-emergent adverse events associated with exposure to Combogesic® IV.
The incidence of treatment-emergent adverse events associated with exposure to Combogesic® IV.
次要结局
- The time course of treatment-emergent adverse events
- The incidence of treatment-related adverse events
- The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)
- Changes in vital sign measurements
- Changes in clinical laboratory values
- Patient’s global evaluation of the study drug
- Define the pharmacokinetic parameters of Combogesic® IV including: Cmax, Tmax, t½, AUC(0-t), Extrapolated AUC(0-∞)
- Consumption of supplemental opioid medication in each 24-hour period as Morphine Milligram Equivalent (MME).
研究者
Chief Scientific Officer
Scientific
Aft Pharmaceuticals Limited
研究点 (5)
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