Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CBP-0276

    Drug

    Oxycodone CBP-0276 orally 600mg QD, orally once a day for 30 days

  • Placebo for CBP-0276

    Drug

    Oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 30 days

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: CBP-0276 600mg QDExperimental treatment 1 intervention
Group B: Placebo for CBP-0276Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of oxycodone use

Number of oxycodone tablets required to controlled the moderate to severe pain management after hip or knee replacement.

Time frame
28 days

Secondary outcomes

1

Oxycodone total requirements

Number of days where the use of oxycodone is required

Time frame
28 days
2

Changes on Quality of Life

Changes in quality of life according to the WHOQOL-BREF score, from baseline and at 28 days post-surgery. This is a 26-item self-report questionnaire that assesses an individual's subjective perception of their well-being and quality of life over the previous two weeks. The raw item scores are converted into transformed domain scores on a standardized scale from 0 to 100. 0 represents the lowest possible perceived quality of life, meanwhile 100 represents the highest.

Time frame
28 days
3

Number of oxycodone tablets required

The number of oxycodone tablets required for pain management at day 15 post-surgical

Time frame
28 days
4

Changes on Pain Intensity

Frequency and intensity of pain evaluated by visual analoge scale (VAS) at day 28 post-surgery and at 3 months of post-surgical follow-up, where 0 is no pain and 10 is the most severy level of pain

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clarent Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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