Clinical trials: Naloxone
Opioid-Induced Constipation
Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily.
- Trial name
- Naxos (NCT03687268)
- Testing
- Naloxone HCl PR tablets
- Where
- 104 sites in Bulgaria, Czechia and 7 more
- Volunteers
- 1,500 people
- Sponsor
- Develco Pharma Schweiz AG
Pain, Opioid Induced Constipation
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients…
- Trial name
- NCT01812733
- Where
- Sweden
- Volunteers
- 37 people
- Sponsor
- Mundipharma AB
Pharmacodynamic
Pharmacodynamic Evaluation of Intranasal Nalmefene
This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to…
- Trial name
- NCT04828005
- Testing
- Nalmefene hydrochloride, Naloxone hydrochloride
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Severe Chronic Pain
A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects
The study is intended to explore changes in the composition and quantity of gut bacteria subject to treatment with strong pain medication. Two pain medications will be compared (OXN PR and OxyPR).
- Trial name
- NCT01915147
- Testing
- OXN PR followed by OxyPR tablets, OxyPR followed by OXN PR tablets
- Where
- 2 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Opioid-Related Disorders, Opiate Dependence
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00725608
- Testing
- buprenorphine/naloxone
- Where
- Austria
- Volunteers
- 339 people
- Sponsor
- Indivior Inc.
Pain
Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
The main objective of the study is to evaluate the patient preference for pain treatment with respect to quality of life in patients with moderate to severe non malignant pain.
- Trial name
- NCT01167699
- Testing
- Oxycodone and naloxone
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Mundipharma Pharmaceuticals B.V.
Opiate Dependence
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
- Trial name
- NCT00901875
- Testing
- Buprenorphine + naloxone (Suboxone)
- Where
- 8 sites in Taiwan
- Volunteers
- 127 people
- Sponsor
- Indivior Inc.
Healthy Volunteer
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers
The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.
- Trial name
- NCT03827629
- Testing
- Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCL Intramuscular (IM) Injection
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics 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
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C
Drug Interaction & Methadone & Buprenorphine
The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on…
- Trial name
- NCT02045693
- Testing
- Methadone, DCV 3DAA FDC, BMS-791325
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Opioid Dependence, on Agonist Therapy
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared…
- Trial name
- ISTART (NCT01908842)
- Testing
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- Where
- 36 sites in United States
- Volunteers
- 759 people
- Sponsor
- Orexo AB
Low Back Pain
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.
- Trial name
- NCT03768466
- Testing
- Brand Name: Targin®
- Where
- 2 sites in South Korea
- Volunteers
- 123 people
- Sponsor
- Mundipharma Korea Ltd
Opiate Dependence
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under…
- Trial name
- NCT02477267
- Testing
- SL spray, SL film
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Back Pain, Low Back Pain
Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.
This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated…
- Conditions
- Back Pain, Low Back Pain, Neuropathic Pain
- Trial name
- NCT01838616
- Testing
- Tapentadol Prolonged Release, Oxycodone/Naloxone Prolonged Release
- Where
- 50 sites in Austria, Germany and 2 more
- Volunteers
- 367 people
- Sponsor
- Grünenthal GmbH
Healthy Volunteer - Complete
Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
WHAT IS THE PURPOSE OF THIS RESEARCH STUDY This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm muscle is approximately the same as…
- Trial name
- NCT07180420
- Testing
- naloxone IM
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- STAT Therapeutics Inc
Healthy Males
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
- Trial name
- NCT01367561
- Testing
- Naloxone, IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Opioid-related Disorders
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active…
- Trial name
- NCT00637000
- Testing
- Buprenorphine soluble film, Buprenorphine/naloxone film strip
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indivior Inc.
Spinal Disorders
An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders
Study Objectives: 1. Primary objective To assess the pain reduction after 8 weeks treatment from baseline (week 0) 2. Secondary objectives To assess the pain reduction after 4 weeks treatment from baseline (week 0) To assess the…
- Trial name
- TALENT (NCT01811238)
- Testing
- Oxycodone/naloxone
- Volunteers
- 240 people
- Sponsor
- Mundipharma Korea Ltd