CBP-0276 to Reduce Opioid Use in Adults Undergoing Major Orthopedic Surgery
ConditionHip or Knee Replacement
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorClarent Biopharma, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CBP-0276
- Placebo for CBP-0276
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov