Clinical trials: Opioid Pain Medication
- Condition Opioid Pain Medication
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
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)
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
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)
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
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid Related Disorders, Opiate Addiction
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could…
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920775
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 360,000 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Chronic Pain
A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy
The purpose of this study is to assess the effectiveness and safety of Durogesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children with chronic pain requiring long-term narcotic…
- Trial name
- NCT00271453
- Testing
- Durogesic® (fentanyl transdermal drug delivery system)
- Volunteers
- 41 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.