Clinical trials: Naloxone
Pain, Constipation
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer…
- Trial name
- NCT01438567
- Testing
- oxycodone/naloxone prolonged release (OXN PR) tablets, oxycodone prolonged release (OxyPR) tablets
- Where
- United Kingdom
- Volunteers
- 270 people
- Sponsor
- Mundipharma Research GmbH & Co KG
HIV, Pharmacokinetics
TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.
TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make more copies of itself.
- Trial name
- NCT00828815
- Testing
- TMC125
- Volunteers
- 22 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Chronic Pain
OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients
This is an open-label, randomized, single-dose, parallel group study. The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN…
- Trial name
- NCT02880475
- Testing
- OXN PR tablet
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Malignant Pain, Non-malignant Pain
To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
- Trial name
- NCT02321397
- Testing
- Oxycodone, Naloxone
- Where
- Germany
- Volunteers
- 155 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Healthy
Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone
Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.
- Trial name
- NCT01260675
- Testing
- Buprenorphine HCl/Naloxone HCl
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC
Opioid Use Disorder
Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).
The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404…
- Trial name
- NCT06406400
- Testing
- AZD4041, Itraconazole, Buprenorphine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Cancer, Pain
A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain
The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone alone in patient's specific type of "chronic cancer pain".
- Conditions
- Cancer, Pain, Constipation
- Trial name
- NCT00513656
- Testing
- Oxycodone, Oxycodone/Naloxone
- Where
- United Kingdom
- Volunteers
- 230 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Stroke, Acute
A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke
This clinical trial was planned for the purpose to re-evaluate the safety and efficacy of naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage.
- Trial name
- NCT05301712
- Testing
- Naloxone hydrochloride 5.0mg/5ml, Sodium Chloride 45mg/5ml
- Where
- South Korea
- Volunteers
- 446 people
- Sponsor
- Samjin Pharmaceutical Co., Ltd.
Pain
Oxycodone-naloxone in Relieving Opioid-related Constipation
The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects…
- Trial name
- NCT00412152
- Testing
- Oxycodone nalaxone prolonged release tablets (OXN)
- Sponsor
- Mundipharma Research GmbH & Co KG
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-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
Opioid Dependence
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine…
- Trial name
- PRO-814 (NCT02180659)
- Testing
- sublingual buprenorphine tablets, Buprenorphine implant
- Volunteers
- 177 people
- Sponsor
- Titan Pharmaceuticals
Opioid Overdose
Naloxone Nasal Spray Pharmacokinetic Study
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization…
- Trial name
- NCT01622504
- Testing
- MVP005, Naloxone hydrochloride solution for injection with mucosal atomization device
- Where
- Jordan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Mitovie Pharma Ltd
Moderate to Severe Pain Due to Diabetic Polyneuropathy
A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
- Trial name
- NCT00944697
- Testing
- Oxycodone Naloxone
- Where
- Germany
- Volunteers
- 98 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Post Operative Pain
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
The purpose of this study is to demonstrate that treatment with OXN PR tablets is non inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on…
- Trial name
- OXN4505 (NCT01083485)
- Testing
- Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets, Oxycodone
- Where
- Finland
- Volunteers
- 137 people
- Sponsor
- Mundipharma Oy
Non Cancer Pain
Targin for Non-cancer Pain
To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release tablets (OXY) based on the Bowel Function…
- Trial name
- NCT01918098
- Testing
- Oxycodone/naloxone prolonged release tablets
- Where
- 31 sites in China
- Volunteers
- 230 people
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
Healthy Volunteer
A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.
- Trial name
- NCT03827642
- Testing
- Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCl Intravenous (IV) Injection
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc