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New treatment option for Hip or Knee Replacement
Official title CBP-0276 to Reduce Opioid Use in Adults Undergoing Major Orthopedic Surgery
ClinicalTrials.gov ID: NCT07687966
What this study is testing
What is CBP-0276?
CBP-0276 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hip or knee replacement.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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
You likely can't join if
- History of respiratory depression, severe bronchial asthma, chronic obstructive pulmonary disease, or acute and/or severe hypercepnia and cor...
- History of gastrointestinal motility disorders (e.g., severe reflux esophagitis, gastroparesis, severe irritable bowel syndrome, active inflammatory...
- 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...
- History of human immunodeficiency virus or positive HIV test result (HIV 1-2 antibodies).
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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). people with immunity to hepatitis B from prior natural infection (defined as HepBsAg negative, HepBcAb positive, and HepBsAb...
- 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 0. Laboratory values out of range and determined...
- 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 0.
- Any other condition that, in the judgment of the PI or Sponsor, determines that the subject is not suitable to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.