NCT05813847已完成3 期
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 1
- 主要终点
- Pain control
研究概览
简要总结
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to sign Informed Consent
- •Scheduled to have inguinal hernia repair
- •Be a reasonably healthy adult 18 - 75 years of age
- •Body mass index ≤ 39 kg/m2
- •If biologically female, not pregnant or planning to become pregnant
- •If biologically male, using acceptable birth control
- •Be willing and able to complete study procedures
排除标准
- •Previously inguinal herniorrhaphy
- •Concurrent painful condition that may require analgesic treatment
- •History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation
- •Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months
- •History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
- •Impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
- •Impaired renal function (e.g., creatinine > 1.5 × ULN).
- •Malignancy in the past year
- •Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
研究组 & 干预措施
CPL-01
Experimental
Local infiltration of CPL-01
干预措施: local anaesthetic injection (Drug)
Ropivacaine HCl
Active Comparator
Local infiltration of Naropin
干预措施: local anaesthetic injection (Drug)
Placebo
Placebo Comparator
Local infiltration of Saline Placebo
干预措施: local anaesthetic injection (Drug)
结局指标
主要结局
Pain control
时间窗: 72 hours
Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Clinical to assess the efficacy of ubidecarenone in patients diagnosed with fibromyalgiaMedDRA version: 14.1Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersFibromyalgiaEUCTR2011-005982-18-ESMónica Saldaña Valderas
已完成
1 期
Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human VolunteersSepsisNCT02328612Tigenix S.A.U.32
进行中（未招募）
1 期
Randomized, double-blind, placebo and active controlled study of the activity ofSAR407899A single-dose on the ability to increase duration of penile rigidity,under experimental condition, in patients with mild to moderate erectiledysfunction - RHOKETMild to moderate erectile dysfunctionMedDRA version: 11.1Level: LLTClassification code 10061461Term: <Manually entered code. Term in E.1.1>EUCTR2009-009936-56-FRsanofi-aventis recherche et développement24
进行中（未招募）
不适用
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label ExtensionEstudio aleatorizado, en doble ciego, controlado con producto activo y con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de distintas dosis de CG5503 en formulación de liberación inmediata en el tratamiento del dolor agudo consecuencia de la cirugía de artroplastia total de cadera, seguido por una extensión abierta de carácter voluntariopainMedDRA version: 8.1Level: LLTClassification code 10033371Term: PainEUCTR2006-004513-18-ESJohnson & Johnson Pharmaceutical Research & Development, L.L.C.1,100
进行中（未招募）
1 期
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label ExtensiopainMedDRA version: 8.1Level: LLTClassification code 10033371Term: PainEUCTR2006-004513-18-FRJohnson & Johnson Pharmaceutical Research & Development, L.L.C.