Clinical trials: Opioid
Opioid-induced Constipation
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.
- Trial name
- NCT00399659
- Testing
- Tegaserod
- Where
- 57 sites in United States
- Volunteers
- 360 people
- Sponsor
- Novartis
Pain, Advanced Cancer
Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer
This 9-week study aimed to determine the efficacy, safety and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced…
- Trial name
- NCT01262651
- Testing
- Nabiximols
- Where
- 72 sites in United States, Belgium and 10 more
- Volunteers
- 397 people
- Sponsor
- GW Pharmaceuticals Ltd
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
Analgesia, Acute Pain
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed…
- Conditions
- Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse
- Trial name
- NCT01530542
- Testing
- oxycodone hydrochloride, marketed oxycodone hydrochloride
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid-use Disorder
Improving Office Based Treatment of Opioid Use Disorder With Technology
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve…
- Trial name
- NCT03586466
- Testing
- BupreCare, Buprenorphine/naloxone, MEMS
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- MedicaSafe, Inc.
Moderate to Severe Opioid-use Disorder
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.
- Trial name
- NCT04995029
- Testing
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- Where
- 29 sites in United States, Canada
- Volunteers
- 785 people
- Sponsor
- Indivior Inc.
Opioid-use Disorder
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC)…
- Trial name
- NCT04948307
- Testing
- OXD01 digital therapy, Standard of Care
- Where
- 21 sites in United States
- Volunteers
- 437 people
- Sponsor
- Orexo AB
Osteoarthritis, Rheumatoid Arthritis
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain, Joint Pain
- Trial name
- NCT01961271
- Testing
- Buprenorphine transdermal patch
- Where
- 16 sites in Hong Kong, Philippines and 1 more
- Volunteers
- 114 people
- Sponsor
- Mundipharma Pte Ltd.
Pain, Postoperative, Hernia, Ventral
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open…
- Conditions
- Pain, Postoperative, Hernia, Ventral, Abdominoplasty, Hysterectomy
- Trial name
- NCT04785638
- Testing
- INL-001 (bupivacaine hydrochloride) implant
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innocoll
Pain
Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany
Among patients receiving opioids for noncancer pain, recent research in North America showed a strong association between doses and opioid-related mortality, especially at dosages exceeding thresholds recommended in recent…
- Trial name
- NCT03778450
- Testing
- Analgesics, Opioid, Non-Opioid Analgesic
- Where
- Germany
- Volunteers
- 3,232 people
- Sponsor
- LinkCare GmbH
Respiratory Depression
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients…
- Trial name
- PRODIGY (NCT02811302)
- Testing
- Capnostream Monitor
- Where
- 16 sites in United States, France and 5 more
- Volunteers
- 1,495 people
- Sponsor
- Medtronic - MITG
Other Acute Postoperative Pain, Prolonged Endotracheal Intubation
Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
- Trial name
- NCT01324544
- Testing
- Buprenorphine IV
- Sponsor
- Purdue Pharma LP
Opioid Use Disorder
Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases…
- Trial name
- NCT02672111
- Testing
- CAM2038 q1w or q4w exposure to SL BPN/NX, CAM2038 q1w or q4w new to BPN treatment
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 228 people
- Sponsor
- Braeburn Pharmaceuticals
Opioid Use Disorder, Chronic Pain
Phase II Pharmacokinetics Study of CAM2038
Phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.
- Trial name
- NCT02710526
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Braeburn Pharmaceuticals
Chronic Pain
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA)
The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pain due to OA.
- Trial name
- NCT00348452
- Testing
- tramadol HCl ER; celecoxib
- Volunteers
- 1,000 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid Withdrawal (Disorder), Opioid Use Disorder
Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms
This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
- Trial name
- NCT07079215
- Testing
- Neurostimulation
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Nu Eyne Co., Ltd.
Healthy
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
The purpose of the present study is to assess prospectively the abuse potential of gabapentin when taken with and without oxycodone compared to placebo in healthy non-drug-dependent recreational opioid drug users under fasted…
- Trial name
- NCT07813026
- Testing
- Oxycodone 20mg, gabapentin 600 mg, Gabapentin 1200mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Viatris Inc.
Opioid Use Disorder
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
- Trial name
- NCT02537574
- Testing
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- Where
- 20 sites in United States
- Volunteers
- 380 people
- Sponsor
- Alkermes, Inc.
Osteoarthritis, Knee
A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in…
- Trial name
- NCT03429049
- Testing
- CNTX-4975-05
- Where
- 33 sites in United States
- Volunteers
- 332 people
- Sponsor
- Centrexion Therapeutics
Chronic Pain
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
- Trial name
- NCT00650182
- Testing
- fentanyl; naltrexone
- Volunteers
- 406 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA