Clinical trials: Opioid
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
Chemotherapy Induced Mucositis, Mouth Pain
A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
The purpose of this study is to characterize the pharmacokinetics and tolerability of buprenorphine patches in children who require opioid pain relief for moderate to severe mouth pain.
- Trial name
- BUP1501 (NCT00947466)
- Testing
- Buprenorphine
- Where
- 2 sites in Denmark, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Mundipharma Research Limited
Pain
A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain
Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.
- Trial name
- NCT02151682
- Testing
- Tapentadol prolonged release, Morphine prolonged release
- Where
- 23 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 73 people
- Sponsor
- Grünenthal GmbH
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
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
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)
Moderate to Severe Acute Postoperative Pain
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within…
- Trial name
- NCT02221674
- Testing
- Tapentadol
- Where
- 7 sites in United States, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Grünenthal GmbH
Pain Management
Neurofeedback-EEG-VR System for Non-opioid Pain Therapy
This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR and Neurofeedback training and their pain…
- Trial name
- NEVR (NCT04551092)
- Testing
- NEVR
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Quantum Applied Science & Research, Inc.
Pain, Postoperative, Pediatrics
An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.
- Trial name
- NCT00666393
- Testing
- fentanyl iontophoretic transdermal system (40mcg)
- Sponsor
- Alza Corporation, DE, USA
Opioid Induced Constipation
Naloxegol US PMR CV Safety.
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically
- Trial name
- NCT02813356
- Testing
- naloxegol, non-PAMORA
- Where
- 2 sites in United States
- Volunteers
- 8,800 people
- Sponsor
- Valinor Pharma LLC
Constipation, Signs and Symptoms, Digestive
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Trial name
- NCT02099591
- Testing
- Naloxegol
- Where
- 16 sites in Denmark, Israel and 3 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
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
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
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, Opiate Dependence
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life…
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00723749
- Testing
- Buprenorphine/Naloxone
- Volunteers
- 384 people
- Sponsor
- Indivior 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
Chronic Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
- Trial name
- NCT01206907
- Testing
- oxymorphone IR
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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
Bone Fractures
Opioid Management for Discharged Emergency Department Patients
The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid…
- Trial name
- NCT06592378
- Testing
- Addinex, Standard Pill Bottle
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Addinex Technologies, Inc.
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.