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New treatment option for Postoperative Pain, Acute
Official title PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)
ClinicalTrials.gov ID: NCT06602271
What this study is testing
What is PF614 capsule?
PF614 capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postoperative pain, acute.
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
- The goal of this clinical trial is to evaluate the analgesic activity of PF614 (an oral oxycodone prodrug extended-release analgesic) for control of postsurgical pain in subjects scheduled for abdominoplasty surgery. The main question to be answered is: To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty.
- Phase 3: a large, late-stage study
- 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 18 to 75
You may be able to join if
- Participant must provide written informed consent prior to the initiation of any protocol specific procedures.
- Male or female participant, between 18 and 75 years of age, inclusive, at the time of Screening.
- Participant must be scheduled to undergo a full abdominoplasty procedure without liposuction with no collateral procedures.
- Participant must have physical status rated as I-II on the American Society of Anesthesiologists rating scale.
- Participant must have a body mass index (BMI) within 18.0 to 32.0 kg/m2, inclusive (minimum weight of at least 50.0 kg).
You likely can't join if
- Participant has a history or presence of a clinically significant abnormality, as assessed by physical examination, medical history...
- Participant has a significant cardiac (e.g., ischemia or infarct, complete bundle branch blocks, symptomatic arrhythmias or predominantly...
- Participant has a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated and is no longer...
- Participant has a history or presence of acute respiratory depression, moderate or severe chronic pulmonary disease, cor pulmonale, delirium tremens...
- Participant has a documented history of, or currently active, seizure disorder (excluding febrile seizures in childhood), or history of clinically...
- Participant has a current painful condition that could confound the interpretation of how well it works, safety, or side effects data in the study...
See the full eligibility criteria
Who can join
- Participant must provide written informed consent prior to the initiation of any protocol specific procedures.
- Male or female participant, between 18 and 75 years of age, inclusive, at the time of Screening.
- Participant must be scheduled to undergo a full abdominoplasty procedure without liposuction with no collateral procedures.
- Participant must have physical status rated as I-II on the American Society of Anesthesiologists rating scale.
- Participant must have a body mass index (BMI) within 18.0 to 32.0 kg/m2, inclusive (minimum weight of at least 50.0 kg).
- If female, participant must be either not of childbearing potential (defined as postmenopausal for at least 1 year and confirmed with follicle stimulating hormone [FSH] \>40 mIU/mL as deemed necessary by the...
- If male, participant must agree to use medically acceptable methods of contraception (diaphragm/sponge/condom with spermicide, vasectomy); female sexual partners of childbearing potential must be using and willing to...
- Must be able to speak, read, and understand English or Spanish sufficiently to allow completion of all study assessments.
- Participant must be willing and able to follow study instructions and be likely to complete all study requirements.
What rules you out
- Participant has a history or presence of a clinically significant abnormality, as assessed by physical examination, medical history, electrocardiograms (ECGs; including a median QT interval corrected for heart rate...
- Participant has a significant cardiac (e.g., ischemia or infarct, complete bundle branch blocks, symptomatic arrhythmias or predominantly non-sinus-conducted rhythm), pulmonary, gastrointestinal, endocrine, metabolic...
- Participant has a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated and is no longer present.
- Participant has a history or presence of acute respiratory depression, moderate or severe chronic pulmonary disease, cor pulmonale, delirium tremens, central nervous system (CNS) depression, or increased cerebrospinal...
- Participant has a documented history of, or currently active, seizure disorder (excluding febrile seizures in childhood), or history of clinically significant head injury or syncope of unknown origin.
- Participant has a current painful condition that could confound the interpretation of how well it works, safety, or side effects data in the study, in the opinion of the investigator.
- Participant has a history or presence of obstructive sleep apnea.
- Participant has a known history of or presence of trypsin deficiency.
- Participant has a history of acute or severe bronchial asthma, hypercarbia, or hypoxia.
- Participant has any chronic gastrointestinal disease or major previous abdominal surgery (e.g., previous abdominoplasty surgery, Billroth procedure, enteroanastomosis, or bariatric surgery, including gastric bands and...
- Participant has a history of pancreatitis, pancreatic insufficiency, gastric ulcers, or gastrointestinal bleeding.
- Participant has evidence of clinically significant hepatic or renal impairment, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× the upper limit of normal (ULN), bilirubin \>2× ULN...
- Participant has used chronic opioid therapy, defined as \>15 mg oral morphine equivalent units per day, for \>3 out of 7 days per week, for \>1 month, within 12 months prior to first study drug administration.
- Participant has used any analgesic medication within 5 half-lives (or, if half-life is unknown, within 48 hours) before the abdominoplasty procedure, or has used chronic non-steroidal anti-inflammatory drug (NSAID)...
- Participant has used systemic steroid therapy within 3 months prior to first study drug administration, excluding over-the-counter (OTC) corticosteroid nasal spray products.
- Participant has used any enzyme-modifying drugs or products, including strong inhibitors of cytochrome P450 (CYP) 3A4 and 2D6 enzymes (e.g., clarithromycin, itraconazole, ketoconazole, nefazodone, posaconazole...
- Participant has used medications that, in the opinion of the investigator, could affect the analgesic response (such as central alpha-adrenergic agents [clonidine and tizanidine], antiepileptic drugs, gabapentinoids...
- Participant has used a glucagon-like peptide-1 (GLP-1) receptor agonist, such as semaglutide, within 30 days prior to first study drug administration.
- Participant is unable to discontinue any of the prohibited medications (Section 9.7.1).
- Participant has a history or presence of any substance or alcohol use disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition, Text Revision (DSM V TR).
- Participant has a positive urine drug screen (UDS) or alcohol breathalyzer test at Screening (other than THC) or on the day of the abdominoplasty procedure. A positive UDS resulting from use of a prescribed medication...
- Participant has a history of suicidal ideation or suicidal behavior in the past 12 months, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS; baseline version).
- Participant has a history of allergy or hypersensitivity to any opioid analgesics, anesthetics, ondansetron, acetaminophen, or NSAIDs.
- Female participant is currently pregnant (positive pregnancy test) or lactating, or is planning to become pregnant within 30 days of last study drug administration.
- Participant is positive for hepatitis B surface antigen (HBsAg), hepatitis C, or HIV.
- Participant has previously participated in a clinical trial using PF614.
- Participant has received any investigational drugs or devices within 4 weeks (or 5 times the half-life of the drug, if known) prior to first study drug administration.
- Participant has any medical condition that, in the opinion of the investigator, might interfere with the study procedures or data integrity or compromise the safety of the participant. Medical records may be requested...
- Participant is an employee of the sponsor or research site personnel directly affiliated with this study, or is their immediate family member, defined as a spouse, parent, child or sibling, whether biological or legally...
- Participant who, in the opinion of the investigator, is considered unsuitable or unlikely to comply with the study protocol for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Houston, Texas, United States; Salt Lake City, Utah, United States. 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.