Clinical trials: Opioids
Pain
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.
- Trial name
- NCT02542098
- Testing
- HYD tablets
- Sponsor
- Purdue Pharma LP
Postoperative Pain
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal…
- Trial name
- NCT00801398
- Testing
- Oxymorphone IR
- Where
- 11 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Chronic Pain
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours.
- Trial name
- NCT00765856
- Testing
- Oxymorphone ER
- Where
- 13 sites in United States
- Volunteers
- 27 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pain
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe…
- Trial name
- NCT01369615
- Testing
- Oxycodone hydrochloride controlled-release tablets
- Where
- 14 sites in United States, Israel
- Volunteers
- 23 people
- Sponsor
- Purdue Pharma LP
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support…
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02897414
- Testing
- Surveillance of state medical examiner databases
- Volunteers
- 13,015 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Cancer Pain
Real-life Observational Study of Cancer Pain Management With Methadone
Study rational. Methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a…
- Trial name
- DUNE (NCT05265442)
- Testing
- Methadone
- Where
- France
- Volunteers
- 136 people
- Sponsor
- RECORDATI GROUP
Opioid Addiction, Opioid Abuse, Continuous Use
Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth.
- Conditions
- Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use, Opioid-Related Disorders
- Trial name
- NCT03394911
- Testing
- 250mg healthy adult male facial skin surface lipid liquid pheromone
- Volunteers
- 500 people
- Sponsor
- Bubba Nicholson
Opioid Withdrawal (Disorder), Opioid Use Disorder
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.
- Trial name
- NCT06711640
- Testing
- LUCEMYRA (lofexidine) tablets
- Where
- United States
- Sponsor
- USWM, LLC (dba US WorldMeds)
Pain
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant…
- Trial name
- NCT01192295
- Testing
- Oxycodone HCl controlled-release tablets
- Where
- 47 sites in United States, Greece and 6 more
- Volunteers
- 155 people
- Sponsor
- Purdue Pharma LP
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary)
Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy.
- Conditions
- Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
- Trial name
- NCT07573150
- Testing
- Infrared Pupillometry
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- NeurOptics Inc
Opioid-Related Disorders, Opiate Addiction
Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B
The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667197
- Testing
- Algorithm to determine overdose from opioid abuse
- Volunteers
- 2,701 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-related Disorders, Opioid Addiction
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02871232
- Testing
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- Volunteers
- 26,500 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Pain, Pain, Acute
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and…
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Trial name
- NCT04080037
- Testing
- Quality IQ Patient Simulations
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Pain
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
- Trial name
- NCT01324570
- Testing
- Buprenorphine transdermal system
- Where
- 22 sites in United States
- Volunteers
- 41 people
- Sponsor
- Purdue Pharma LP
Pain, Cancer
Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.
The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.
- Trial name
- NCT00262678
- Testing
- EN3267
- Where
- United States
- Sponsor
- Kyowa Kirin Co., Ltd.
Postoperative Pain
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
- Trial name
- Palladone (NCT00465647)
- Testing
- Hydromorphone
- Where
- 14 sites in United States
- Volunteers
- 116 people
- Sponsor
- Purdue Pharma LP