Clinical trials: Naloxone
Healthy
Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects
PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and cortisol responses to naloxone by blocking the effect of the CRH increases induced by naloxone at the postsynaptic receptors.
- Trial name
- NCT00580190
- Testing
- alprazolam, PF-00572778
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid Overdose
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
- Trial name
- NCT04713709
- Testing
- Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Moderate to Severe Idiopathic RLS With Daytime Symptoms
Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms
The primary objective for the 12-week Titration-/Maintenance Period is: To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.
- Trial name
- NCT01112644
- Testing
- Oxycodone naloxone prolonged release tablets (OXN PR)
- Where
- 3 sites in Germany, Spain and 1 more
- Volunteers
- 205 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Low Back Pain
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low…
- Trial name
- NCT01427270
- Testing
- Oxycodone/Naloxone controlled-release, Oxycodone HCl controlled-release
- Where
- 194 sites in United States, Czechia and 2 more
- Volunteers
- 455 people
- Sponsor
- Purdue Pharma LP
Opioid Induced Constipation (OIC)
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with…
- Trial name
- NCT00600119
- Testing
- NKTR-118
- Where
- 33 sites in United States
- Volunteers
- 207 people
- Sponsor
- AstraZeneca
Osteoarthritis, Back Pain
A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis.
- Trial name
- NCT00784810
- Testing
- Oxycodone/Naloxone, Codeine/Paracetamol
- Where
- United Kingdom
- Volunteers
- 247 people
- Sponsor
- Napp Pharmaceuticals Limited
Low Back Pain
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid…
- Trial name
- NCT01358526
- Testing
- Oxycodone/Naloxone Controlled-release
- Where
- 151 sites in United States
- Volunteers
- 1,095 people
- Sponsor
- Purdue Pharma LP
Healthy
A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone. NIDA Contract No. HHSN271200577414C
- Trial name
- NCT00880841
- Testing
- Buprenorphine / Naloxone
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC
Infection, Human Immunodeficiency Virus
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a…
- Trial name
- NCT02666001
- Testing
- BMS-663068, Methadone, Buprenorphine and Norbuprenorphine
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
Hepatitis C, Opioid-Related Disorders
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose…
- Trial name
- NCT01275599
- Testing
- telaprevir, buprenorphine/naloxone
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis…
- Conditions
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Sézary Syndrome
- Trial name
- NCT02811783
- Testing
- Naloxone Hydrochloride Lotion, 0.5%
- Where
- 16 sites in United States
- Volunteers
- 59 people
- Sponsor
- Elorac, Inc.
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
Subjects With Moderate to Severe, Chronic Nonmalignant Pain
A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain
The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.
- Trial name
- NCT01971632
- Testing
- Oxycodone & naloxone combination, prolonged release
- Volunteers
- 463 people
- Sponsor
- Mundipharma Research GmbH & Co KG
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.
Opioid Dependency
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based…
- Trial name
- RIME (NCT00955162)
- Testing
- Buprenorphine (Subutex), Buprenorphine/naloxone (Suboxone)
- Where
- 20 sites in France
- Volunteers
- 270 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.
- Trial name
- NCT05062577
- Testing
- ASP8062, buprenorphine/naloxone
- Sponsor
- Astellas Pharma Global Development, Inc.
Fentanyl Overdose, Fentanyl Poisoning
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of…
- Trial name
- NCT07459166
- Testing
- Naloxone Hydrochloride, Fentanyl, Sterile Saline
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Clear Scientific, Inc.
Constipation
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
- Trial name
- HMX3501 (NCT00992576)
- Testing
- Active Hydromorphone PR + Active Naloxone PR
- Where
- 14 sites in Australia, Austria and 12 more
- Volunteers
- 600 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Biological Availability
Pharmacokinetics of Fentanyl Following Intravenous and Oral Routes of Administration in Healthy Volunteers
The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of fentanyl following oral administration.
- Trial name
- NCT00714558
- Testing
- Fentanyl citrate; Naltrexone; Naloxone
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.