Inguinal HerniorrhaphyPhase 2NCT05080959
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
A Phase 2 study testing CPL-01 and Naropin 150 MG Per 20 ML Injection in people with Inguinal Herniorrhaphy, run by Cali Pharmaceuticals LLC at 5 sites in United States.
Trial summary
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Herniorrhaphy
- What is being tested?
- CPL-01 and Naropin 150 MG Per 20 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jul 2021to 10 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to sign the informed consent form (ICF) prior to study participation.
- In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization
- Plan to undergo an elective open inguinal herniorrhaphy with mesh under general anesthesia without collateral procedures or additional surgeries. Endotracheal intubation is not required.
- Have a body mass index ≤ 39 kg/m2.
- In the judgment of the Investigator, be willing and able to complete study procedures and pain scales and to communicate meaningfully with study personnel and return for outpatient follow-up visits as required.
Who cannot join
- Has previously undergone herniorrhaphy with the exception of a pediatric herniorrhaphy prior to 2 years of age.
- Has undergone 3 or more surgeries within 12 months prior to signing the ICF, other than for diagnostic procedures (e.g., colonoscopy).
- Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition including a clinically significant existing arrhythmia, bundle branch block or abnormal electrocardiogram (ECG), myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.
- Has history or evidence of impaired liver function (e.g., ALT > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
- Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).
- Has a history of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix.
Show all 18Show fewer
- Has or has had active COVID-19 infection within 3 months prior to surgery.
- Has a history of, or positive test results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody at Screening.
- Within 7 days prior to the scheduled surgery, be taking any central nervous system ( CNS) active agent as an analgesic adjunct medication, such as anticonvulsants, gabapentinoids, antidepressants (such as serotonin and norepinephrine reuptake inhibitors [SNRIs], selective serotonin reuptake inhibitors [SSRIs], and tricyclic antidepressants), benzodiazepines, sedative-hypnotics, clonidine and other central alpha-2 agents (e.g., tizanidine), ketamine, or muscle relaxants. These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery. The dose must remain stable throughout the study.
- Use of benzodiazepines and non-benzodiazepines (eszopiclone, ramelteon, zaleplon and zolpidem) is permitted to treat insomnia during the postoperative period.
- Within 7 days prior to the scheduled surgery and throughout the study, be taking antiarrhythmics except beta-blockers, digoxin, warfarin (see exception below), lithium, or aminoglycosides or other antibiotics for an infection (ophthalmic use or for treatment or prophylaxis of postoperative surgical site infections is permitted).
- Within 14 days prior to the scheduled surgery and throughout the inpatient period, be taking or using any cannabidiol-containing products, dietary supplements, or over-the- counter (OTC) preparations (e.g., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian).
- Within 28 days prior to the scheduled surgery, has received parenteral or oral corticosteroid treatment (steroid inhaler for allergy or asthma treatment, topical steroid for a non-clinically significant skin condition not involving the area of surgery or ophthalmic steroids are permissible).
- Is taking an antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
- In the opinion of the Investigator, within the past year has a history of illicit drug use or prescription medicine or alcohol abuse (regularly drinks > 4 units of alcohol per day, where 1 unit = 8 ounces beer, 3 ounces of wine, or 1 ounce of spirits).
- Has a positive alcohol breath/saliva test result indicative of alcohol use, or a positive urine drug screen result indicative of illicit drug use (unless results can be explained by a current prescription or acceptable OTC medication at Screening as determined by the Investigator) at Screening and/or prior to surgery.
- Has previously participated in a clinical study with CPL-01.
- Has participated in another clinical trial or used an investigational product within 30 d days or 5 half-lives, whichever is longer, prior to the planned surgery or is scheduled to receive any other investigational product while participating in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials
Anaheim, California, 92801
First Surgical Hospital
Bellaire, Texas, 77401
Arizona Research Center
Phoenix, Arizona, 85053
Jean Brown Research
Salt Lake City, Utah, 84107
Shoals Medical Trials, Inc
Sheffield, Alabama, 35660
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in Postoperative Pain After Open Inguinal Herniorrhaphy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
Read the detailed description
A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy.
- Conditions
- Inguinal Herniorrhaphy
- Being tested
- CPL-01, Naropin 150 MG Per 20 ML Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL-01Drug
Also called Infiltration of study drug
Subjects will receive a single dose
Naropin 150 MG Per 20 ML InjectionDrug
Also called Infiltration of study drug
Subjects will receive a single dose
PlaceboDrug
Also called Infiltration of study drug
Subjects will receive a single dose
| Study group | Role | What they receive |
|---|---|---|
| CPL-01 | Experimental | CPL-01 200mg, 400mg, 600mg Receives: Drug: CPL-01 |
| Naropin | Experimental | 150mg Receives: Drug: Naropin 150 MG Per 20 ML Injection |
| Placebo | Experimental | 30mL normal saline (0.9%) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the NRS-A for pain (Primary Endpoint)
Summary (area under the curve) through 72 hours of the Numeric rating scale with activity score for pain, where 0 is no pain and 10 is worst possible pain
Measured: 0 - 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start28 Jul 2021
- Primary completion31 Dec 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniorrhaphyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cali Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, MD, Study chair, Cali Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080959
- Sponsor's protocol ID
- CPL-01-201
- Status last verified
- Oct 2021
- First submitted
- 14 Aug 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in Postoperative Pain After Open Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT05080959
- Acronym / sponsor ID
- CPL-01-201
- Conditions
- Inguinal Herniorrhaphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cali Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 18 Oct 2021 (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.
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
Detailed description
A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPL-01 | Experimental | Drug: CPL-01CPL-01 200mg, 400mg, 600mg |
| Naropin | Experimental | Drug: Naropin 150 MG Per 20 ML Injection150mg |
| Placebo | Experimental | Drug: Placebo30mL normal saline (0.9%) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be willing and able to sign the informed consent form (ICF) prior to study participation.
- In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization
- Plan to undergo an elective open inguinal herniorrhaphy with mesh under general anesthesia without collateral procedures or additional surgeries. Endotracheal intubation is not required.
- Have a body mass index ≤ 39 kg/m2.
- In the judgment of the Investigator, be willing and able to complete study procedures and pain scales and to communicate meaningfully with study personnel and return for outpatient follow-up visits as required.
Key exclusion criteria (18 listed)
- Has previously undergone herniorrhaphy with the exception of a pediatric herniorrhaphy prior to 2 years of age.
- Has undergone 3 or more surgeries within 12 months prior to signing the ICF, other than for diagnostic procedures (e.g., colonoscopy).
- Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition including a clinically significant existing arrhythmia, bundle branch block or abnormal electrocardiogram (ECG), myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.
- Has history or evidence of impaired liver function (e.g., ALT > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
- Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).
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 |
|---|---|---|
| CPL-01Also: Infiltration of study drugSubjects will receive a single dose | Drug | CPL-01 |
| Naropin 150 MG Per 20 ML InjectionAlso: Infiltration of study drugSubjects will receive a single dose | Drug | Naropin |
| PlaceboAlso: Infiltration of study drugSubjects will receive a single dose | Drug | Placebo |
Primary outcome
AUC of the NRS-A for pain (Primary Endpoint)
Time frame: 0 - 72 hours
Summary (area under the curve) through 72 hours of the Numeric rating scale with activity score for pain, where 0 is no pain and 10 is worst possible pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Inguinal Herniorrhaphy
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Not yet recruiting
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Unilateral, Postoperative Pain
Recruiting
Effect of Anterior Iliac Block on Postoperative Analgesia and Patient Satisfaction in Inguinal Hernia Repair Surgery
Anterior Ilıac Block, Hernia Surgery
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. This study is not recruiting at the moment.
Erol Onel, MD study chair
Cali Biosciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPL-01 and Naropin 150 MG Per 20 ML Injection in people with Inguinal Herniorrhaphy, run by Cali Pharmaceuticals LLC at 5 sites in United States.
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 5 inclusion and 18 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: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of the NRS-A for pain (Primary Endpoint) (time frame: 0 - 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.