Chronic Pain Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
| Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
| Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
| Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
| Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
| Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
| Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
| Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
| Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
| Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
| Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
| Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
| Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|