Clinical trials: Analgesic, Opioid
Low Back Pain, Osteoarthritis
Long-term Open-Label Safety Study to Evaluate EN3409
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended…
- Conditions
- Low Back Pain, Osteoarthritis, Neuropathic Pain
- Trial name
- NCT01755546
- Testing
- EN3409
- Where
- 57 sites in United States
- Volunteers
- 304 people
- Sponsor
- BioDelivery Sciences International
Pain, Postoperative, Analgesics, Opioid
Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy
The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system with integrated mobile CBT but…
- Trial name
- P1RESPECT (NCT04836169)
- Testing
- InCaveo's EOA system with integrated mobile CBT
- Volunteers
- 30 people
- Sponsor
- InCaveo
Pain
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean…
- Trial name
- NCT01165281
- Testing
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- Where
- 52 sites in Japan, South Korea
- Volunteers
- 343 people
- Sponsor
- Janssen Research & Development, LLC
Cancer of Endometrium, Cancer of Cervix
Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients
Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant.
- Trial name
- NCT05742711
- Testing
- Primary Relief
- Where
- India
- Volunteers
- 48 people
- Sponsor
- DyAnsys, Inc.
Analgesia Disorder, Pain
A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management
This is a randomized, double blind, placebo-controlled, single dose study to assess the safety and efficacy of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.
- Trial name
- NCT02468128
- Testing
- Sebacoyl Dinalbuphine Ester
- Where
- 6 sites in Taiwan
- Volunteers
- 221 people
- Sponsor
- Lumosa Therapeutics Co., Ltd.
Pain, Osteoarthritis, Hip
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee…
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Trial name
- NCT00980798
- Testing
- OROS hydromorphone HCl
- Where
- 12 sites in Czechia, Romania and 2 more
- Volunteers
- 288 people
- Sponsor
- Janssen-Cilag International NV
Acute Pain
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
- Trial name
- NCT00226395
- Testing
- Oxymorphone immediate release
- Where
- 21 sites in United States
- Volunteers
- 320 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pain, Low Back Pain
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain.
- Trial name
- NCT01431742
- Testing
- BEMA Buprenorphine
- Where
- United States
- Sponsor
- BioDelivery Sciences International
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 Dependence
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
- Trial name
- PRO-810 (NCT00768482)
- Testing
- Probuphine (buprenorphine implant), Sublingual Buprenorphine
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Titan Pharmaceuticals
Low Back Pain
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects…
- Trial name
- NCT01427283
- Testing
- Oxycodone/Naloxone controlled-release, Oxycodone HCl controlled-release
- Where
- 149 sites in United States
- Volunteers
- 450 people
- Sponsor
- Purdue Pharma LP
Chronic Pain
A Study of JNS020QD in Patients With Chronic Pain
The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who switched from opioid analgesics, as well as the safety and efficacy of long-term treatment (52…
- Trial name
- NCT01493245
- Testing
- JNS020QD
- Where
- 18 sites in Japan
- Volunteers
- 77 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
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, Analgesics, Opioid
A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain
The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid therapy on a daily basis for chronic pain…
- Trial name
- NCT00410878
- Testing
- OROS Hydromorphone HCI (slow release)
- Volunteers
- 22 people
- Sponsor
- Alza Corporation, DE, USA
Pain, Cancer
A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to…
- Trial name
- NCT00644787
- Testing
- Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase), Fentanyl 3-day transdermal patch (Double Blind Phase)
- Where
- 43 sites in Japan
- Volunteers
- 156 people
- Sponsor
- Janssen Pharmaceutical K.K.
Hysterectomy, Postoperative
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal…
- Trial name
- NCT00478023
- Testing
- Morphine, CG5503 IR
- Where
- 52 sites in Hungary, Latvia and 7 more
- Volunteers
- 854 people
- Sponsor
- Grünenthal GmbH
Analgesia Disorder
Study of PHN131 in Healthy Volunteers
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers
- Trial name
- NCT02192151
- Where
- Taiwan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PhytoHealth Corporation
Analgesics, Opioid, Pain
Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain
The primary purpose of this study was to characterize the pain control achieved with long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic cancer pain and the secondary purpose was to…
- Trial name
- NCT00410787
- Testing
- OROS hydromorphone HCI (slow release)
- Volunteers
- 68 people
- Sponsor
- Alza Corporation, DE, USA
Pain, Analgesics
A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal…
- Conditions
- Pain, Analgesics, Opioid
- Trial name
- NCT00410644
- Testing
- OROS Hydromorphone HCI
- Volunteers
- 463 people
- Sponsor
- Alza Corporation, DE, USA