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Last Updated: August 6, 2020

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CLINICAL TRIALS PROFILE FOR FENTANYL-87

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505(b)(2) Clinical Trials for Fentanyl-87

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00620828 The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty Completed Pfizer Phase 4 2007-05-01 The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination NCT00620828 The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty Completed Duke University Phase 4 2007-05-01 The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
OTC NCT01691690 Analgesic Effect of IV Acetaminophen in Tonsillectomies Active, not recruiting Nationwide Children's Hospital Phase 2 2012-10-01 Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid CB1 receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
New Formulation NCT01717157 A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers Completed Janssen Research & Development, LLC Phase 1 2012-08-01 The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.
New Formulation NCT02608320 A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Heal Completed Janssen Research & Development, LLC Phase 1 2015-11-01 The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
New Formulation NCT02617758 Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants Completed Janssen Research & Development, LLC Phase 1 2015-11-01 The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
OTC NCT02929589 Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy Not yet recruiting Mike O'Callaghan Federal Hospital N/A 2017-04-01 This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fentanyl-87

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000273 A Laboratory Model for Heroin Abuse Medications - 8 Completed National Institute on Drug Abuse (NIDA) Phase 2 1995-08-01 The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00000273 A Laboratory Model for Heroin Abuse Medications - 8 Completed New York State Psychiatric Institute Phase 2 1995-08-01 The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00003000 Morphine for the Treatment of Pain in Patients With Breast Cancer Completed Roswell Park Cancer Institute N/A 1992-05-01 RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00004424 Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy Completed Case Western Reserve University N/A 1996-07-01 OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy Completed FDA Office of Orphan Products Development N/A 1996-07-01 OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00027014 Herb-Opioid Interactions Completed National Center for Complementary and Integrative Health (NCCIH) Phase 4 2001-09-01 This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
NCT00095251 MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status Active, not recruiting Vanderbilt University Medical Center Phase 2 2004-08-01 Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fentanyl-87

Condition Name

Condition Name for Fentanyl-87
Intervention Trials
Pain 147
Postoperative Pain 75
Pain, Postoperative 64
Anesthesia 45
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Condition MeSH

Condition MeSH for Fentanyl-87
Intervention Trials
Pain, Postoperative 171
Breakthrough Pain 39
Vomiting 32
Labor Pain 29
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Clinical Trial Locations for Fentanyl-87

Trials by Country

Trials by Country for Fentanyl-87
Location Trials
United States 754
Egypt 103
Canada 82
Korea, Republic of 63
Turkey 40
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Trials by US State

Trials by US State for Fentanyl-87
Location Trials
California 59
New York 54
Texas 54
North Carolina 43
Illinois 40
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Clinical Trial Progress for Fentanyl-87

Clinical Trial Phase

Clinical Trial Phase for Fentanyl-87
Clinical Trial Phase Trials
Phase 4 410
Phase 3 155
Phase 2/Phase 3 38
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Clinical Trial Status

Clinical Trial Status for Fentanyl-87
Clinical Trial Phase Trials
Completed 496
Recruiting 254
Not yet recruiting 225
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Clinical Trial Sponsors for Fentanyl-87

Sponsor Name

Sponsor Name for Fentanyl-87
Sponsor Trials
Assiut University 29
Mansoura University 28
Yonsei University 22
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Sponsor Type

Sponsor Type for Fentanyl-87
Sponsor Trials
Other 1194
Industry 217
NIH 17
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