Hip or Knee ReplacementPhase 2CBP0276-OpdNCT07687966
CBP-0276 to Reduce Opioid Use in Adults Undergoing Major Orthopedic Surgery
A Phase 2 study testing CBP-0276 in people with Hip or Knee Replacement, run by Clarent Biopharma, Inc. at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hip or Knee Replacement
- What is being tested?
- CBP-0276
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 8 May 2026to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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 0. 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Innovacion y Desarrollo de Estrategias en Salud
Mexico City, 14340
Diana M Andrade Platas, MD, MSc, +525535209755, diana.andrade@elemental.org.mx
Tom Jilmer Castillo, MD, +523324120245, tom.castillo@idecsa.com.mx
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Hip or Knee Replacement
- Being tested
- CBP-0276, Placebo for CBP-0276
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-0276Drug
Oxycodone CBP-0276 orally 600mg QD, orally once a day for 30 days
Placebo for CBP-0276Drug
Oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| CBP-0276 600mg QD | Experimental | First group (n=40) will receive oxycodone (standard of care) + CBP-0276 at a dose of 600 mg, orally once daily for 28 days. Receives: Drug: CBP-0276 |
| Placebo for CBP-0276 | Placebo comparator | Second group (n=40) will receive oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 28 days Receives: Drug: Placebo for CBP-0276 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of oxycodone use
Number of oxycodone tablets required to controlled the moderate to severe pain management after hip or knee replacement.
Measured: 28 days
Secondary outcomes (5)
Oxycodone total requirements
Number of days where the use of oxycodone is required
Measured: 28 days
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.
Measured: 28 days
Number of oxycodone tablets required
The number of oxycodone tablets required for pain management at day 15 post-surgical
Measured: 28 days
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
Measured: 28 days
Chnages on inflamatory cytokines
Changes on inflamatory cytokines between baseline and end of treatment (day 28)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start8 May 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip or Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarent Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge González Thompson, MD, Principal investigator, Innovacion y Desarrollo de Estrategias en Salud SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687966
- Sponsor's protocol ID
- CBP0276-PillRed2026
- Acronym
- CBP0276-Opd
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949Mattia C, Coluzzi F, Sonnino D, Anker-Moller E. Efficacy and safety of fentanyl HCl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management for patient subgroups. Eur J Anaesthesiol. 2010 May;27(5):433-40. doi: 10.1097/EJA.0b013e3283349d82.
PubMed 20186064Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
PubMed 30983589DeWire SM, Yamashita DS, Rominger DH, Liu G, Cowan CL, Graczyk TM, Chen XT, Pitis PM, Gotchev D, Yuan C, Koblish M, Lark MW, Violin JD. A G protein-biased ligand at the mu-opioid receptor is potently analgesic with reduced gastrointestinal and respiratory dysfunction compared with morphine. J Pharmacol Exp Ther. 2013 Mar;344(3):708-17. doi: 10.1124/jpet.112.201616. Epub 2013 Jan 8.
PubMed 23300227Padi SSV, Shi XQ, Zhao YQ, Ruff MR, Baichoo N, Pert CB, Zhang J. Attenuation of rodent neuropathic pain by an orally active peptide, RAP-103, which potently blocks CCR2- and CCR5-mediated monocyte chemotaxis and inflammation. Pain. 2012 Jan;153(1):95-106. doi: 10.1016/j.pain.2011.09.022. Epub 2011 Oct 26.
PubMed 22033364Noda M, Tomonaga D, Kitazono K, Yoshioka Y, Liu J, Rousseau JP, Kinkead R, Ruff MR, Pert CB. Neuropathic pain inhibitor, RAP-103, is a potent inhibitor of microglial CCL1/CCR8. Neurochem Int. 2018 Oct;119:184-189. doi: 10.1016/j.neuint.2017.12.005. Epub 2017 Dec 14.
PubMed 29248693
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07687966
- Acronym / sponsor ID
- CBP0276-Opd / CBP0276-PillRed2026
- Conditions
- Hip or Knee Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Clarent Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| CBP-0276 600mg QD | Experimental | Drug: CBP-0276First group (n=40) will receive oxycodone (standard of care) + CBP-0276 at a dose of 600 mg, orally once daily for 28 days. |
| Placebo for CBP-0276 | Placebo comparator | Drug: Placebo for CBP-0276Second group (n=40) will receive oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 28 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP-0276Oxycodone CBP-0276 orally 600mg QD, orally once a day for 30 days | Drug | CBP-0276 600mg QD |
| Placebo for CBP-0276Oxycodone (standard of care) + placebo for CBP-0276, orally once daily for 30 days | Drug | Placebo for CBP-0276 |
Primary outcome
Frequency of oxycodone use
Time frame: 28 days
Number of oxycodone tablets required to controlled the moderate to severe pain management after hip or knee replacement.
5 secondary outcomes
Oxycodone total requirements
Time frame: 28 days
Changes on Quality of Life
Time frame: 28 days
Number of oxycodone tablets required
Time frame: 28 days
Changes on Pain Intensity
Time frame: 28 days
Chnages on inflamatory cytokines
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Background: PubMed 20186064Mattia C, Coluzzi F, Sonnino D, Anker-Moller E. Efficacy and safety of fentanyl HCl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management for patient subgroups. Eur J Anaesthesiol. 2010 May;27(5):433-40. doi: 10.1097/EJA.0b013e3283349d82.
- Background: PubMed 30983589Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
- Background: PubMed 23300227DeWire SM, Yamashita DS, Rominger DH, Liu G, Cowan CL, Graczyk TM, Chen XT, Pitis PM, Gotchev D, Yuan C, Koblish M, Lark MW, Violin JD. A G protein-biased ligand at the mu-opioid receptor is potently analgesic with reduced gastrointestinal and respiratory dysfunction compared with morphine. J Pharmacol Exp Ther. 2013 Mar;344(3):708-17. doi: 10.1124/jpet.112.201616. Epub 2013 Jan 8.
- Background: PubMed 22033364Padi SSV, Shi XQ, Zhao YQ, Ruff MR, Baichoo N, Pert CB, Zhang J. Attenuation of rodent neuropathic pain by an orally active peptide, RAP-103, which potently blocks CCR2- and CCR5-mediated monocyte chemotaxis and inflammation. Pain. 2012 Jan;153(1):95-106. doi: 10.1016/j.pain.2011.09.022. Epub 2011 Oct 26.
- Background: PubMed 29248693Noda M, Tomonaga D, Kitazono K, Yoshioka Y, Liu J, Rousseau JP, Kinkead R, Ruff MR, Pert CB. Neuropathic pain inhibitor, RAP-103, is a potent inhibitor of microglial CCL1/CCR8. Neurochem Int. 2018 Oct;119:184-189. doi: 10.1016/j.neuint.2017.12.005. Epub 2017 Dec 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge González Thompson, MD principal investigator
Innovacion y Desarrollo de Estrategias en Salud SA de CV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBP-0276 in people with Hip or Knee Replacement, run by Clarent Biopharma, Inc. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Gutiérrez Castrellón, MD, PhD (+525554198746, pedro.gutierrez@elemental.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of oxycodone use (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07687966, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.