Proof-of-concept, Double-blind, Randomized Clinical Study to Evaluate the Safety and Efficacy of CBP-0276 at Doses of 600 mg/Day vs Placebo in Reducing Opioid Use in Pain Management in Adult Patients Undergoing Major Orthopedic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Frequency of oxycodone use
研究概览
简要总结
Randomized, double-blind, clinical study to evaluate the safety and efficacy of CBP-0276 at doses of 600 mg/day in reducing opioid use in pain management in adult patients undergoing major orthopedic surgery. Subjects will be allocated in 2 groups. One group will receive oxycodone (standard of care) + CBP-0276 at a dose of 600 mg, orally once daily for 28 days. A second group will receive oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 28 days
详细描述
Randomized, Phase 2, Proof-of-concept, double-blind, parallel-group, placebo controlled clinical study to evaluate the safety and efficacy of CBP-0276 at doses of 600 mg/day in reducing opioid use in pain management in adult patients undergoing major orthopedic surgery. Subjects will be allocated in 2 groups. One group (n=40) will receive oxycodone (standard of care) + CBP-0276 at a dose of 600 mg, orally once daily for 28 days. A second group (n=40) will receive oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 28 days. Primary outcome is the reduction on the number of oxycodone tablets required to controlled the moderate to severe pain management during the 28 days post-major orthopaedic surgery. Secondary and Exploratory outcomes are: A) Number of days where the use of oxycodone is required; B) Changes in quality of life according to the WHOQOL-BREF score, from baseline and at 28 days post-surgery; C) The number of oxycodone tablets required for pain management at day 15 post-surgical; D) Frequency and intensity of pain at day 28 post-surgery and at 3 months of post-surgical follow-up; E) Changes on inflamatory cytokines between baseline and end of treatment (day 28) Characteristics of the subject to be enrolled included age between 40 and 75y, male or female, BMI 18.5 to 35, under surgery of hip or knee replacement.
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)
盲法说明
The participant, study operating staff and Sponsor will remain blind to the assigned treatment. To ensure such masking, a non-blind pharmacist delegated by the Principal Investigator will be responsible for dispensing the investigational product. The Sponsor and the research center will have two blind/non-blind teams. The study interventions (CLT-0276 and placebo) will have the same pharmaceutical form (capsule) and will be dispensed in containers/dosers previously identified with the ID number that corresponds to each subject. The containers will be made of plastic and identical for both products and labelled with the following information: protocol number and ID number. The analysts' blindness will remain with respect to the randomization scheme
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •Age between 40 and 75 years (inclusive)
- •Body weight between 50 and 90 Kg
- •Post-surgical patient of major orthopedic surgery, with opioid treatment (oxycodone) at discharge by treating physician
- •Physical status of ASA I to III
- •Be able and willing to read, understand, sign, and date the Informed
- •Consent Form prior to entering the study.
- •Woman of childbearing age with effective contraception, not pregnant, not on breastfeeding, not pregnancy plans during the development of the study, postmenopausal, defined by cessation of menstruation for at least 12 consecutive months and confirmed by serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or surgically sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) and not undergoing in vitro fertilization or other fertility treatments)
- •Men agreed to use contraception or remain abstinent (when this is the subject's usual and preferred lifestyle)Be willing to complete all study visits and procedures.
排除标准
- •History of respiratory depression, severe bronchial asthma, chronic obstructive pulmonary disease, or acute and/or severe hypercepnia and cor pulmonale.
- •History of gastrointestinal motility disorders (e.g., severe reflux esophagitis, gastroparesis, severe irritable bowel syndrome, active inflammatory bowel disease, and paralytic ileus).
- •History of depression, seizures, and epilepsy.
- •Uncontrolled hypertension: systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg confirmed by at least two measurements.
- •History of allergic reactions, anaphylactic reactions, severe systemic hypersensitivity, or any allergic reaction that, in the opinion of the Principal Investigator or his /her delegate, is likely to be exacerbated by the study drug (RAP-103 and oxycodone).
- •History of human immunodeficiency virus or positive HIV test result (HIV 1-2 antibodies).
- •History of hepatitis C infection or positive hepatitis C virus (HCVAb) antibody screening result.
- •Current hepatitis B (HBV) infection (defined as positive for HepBsAg and/or HepBcAb). Subjects with immunity to hepatitis B from prior natural infection (defined as HepBsAg negative, HepBcAb positive, and HepBsAb positive) or vaccination (defined as HepBsAg negative, HepBCAb negative, and HepBSAb positive) are eligible to participate in the study.
- •Transcutaneous oxygen saturation (SpO₂) <90%.
- •Patients with severe liver or kidney disease.
- •Patients with immunosuppression, neoplasms, or HIV infection.
- •Active substance use disorder (SUD) or within the previous 12 months, including opioid, alcohol, benzodiazepines, or any other substance with potential for abuse.
- •Patients with the use of antipsychotic medications.
- •Any clinical condition that makes it difficult to self-assess pain.
- •Recent opioid use (14 days prior recruitment).
- •Previous exposure to RAP-103 or DAPTA (T-Peptide) at any time in your life.
- •Abnormal and clinically significant results at the discretion of the Principal investigator (or his/her delegate) in the laboratory tests and electrocardiogram of visit
- •Laboratory values out of range and determined to be not clinically significant at the discretion of the Principal Investigator or his/her delegate may be repeated on one occasion, the subject may be enrolled if the repeated value is within the normal range.
- •Participation in any other investigational study with drugs, biologics, medical devices, or treatment with an investigational product or therapy approved for investigational use within 30 days or 5 halflives at visit
- •Any other condition that, in the judgment of the PI or Sponsor, determines that the subject is not suitable to participate in the study.
结局指标
主要结局
Frequency of oxycodone use
时间窗: 28 days
Number of oxycodone tablets required to controlled the moderate to severe pain management after hip or knee replacement.
次要结局
- Oxycodone total requirements(28 days)
- Changes on Quality of Life(28 days)
- Number of oxycodone tablets required(28 days)
- Changes on Pain Intensity(28 days)
- Chnages on inflamatory cytokines(28 days)