Clinical trials: Buprenorphine
Osteoarthritis
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
- Trial name
- NCT01135524
- Testing
- Buprenorphine transdermal patch
- Where
- 89 sites in United States
- Volunteers
- 196 people
- Sponsor
- Purdue Pharma LP
Healthy
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc.
- Trial name
- NCT01157169
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Hepatitis C Virus
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of…
- Trial name
- NCT01396005
- Testing
- boceprevir, methadone, buprenorphine/naloxone
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
Low Back Pain, Osteoarthritis
Long-term Open-Label Safety Study to Evaluate EN3409
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended…
- Conditions
- Low Back Pain, Osteoarthritis, Neuropathic Pain
- Trial name
- NCT01755546
- Testing
- EN3409
- Where
- 57 sites in United States
- Volunteers
- 304 people
- Sponsor
- BioDelivery Sciences International
Osteoarthritis, Rheumatoid Arthritis
Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity
This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain, Joint Pain
- Trial name
- NCT02519387
- Testing
- Buprenorphine Transdermal Patch
- Where
- 3 sites in Malaysia
- Volunteers
- 78 people
- Sponsor
- Mundipharma Pharmaceuticals Sdn. Bhd.
Pain
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
- Trial name
- NCT02634788
- Testing
- Buprenorphine
- Where
- 4 sites in United States
- Volunteers
- 322 people
- Sponsor
- INSYS Therapeutics Inc
Postoperative Pain
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative…
- Trial name
- NCT00403234
- Testing
- Buprenorphine transdermal patch
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Purdue Pharma LP
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
Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD).
- Trial name
- NCT05704543
- Testing
- Buprenorphine Extended-Release Injection
- Where
- 6 sites in United States
- Volunteers
- 132 people
- Sponsor
- Indivior Inc.
Healthy
Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.
- Trial name
- NCT01259115
- Testing
- Buprenorphine transdermal patch, Ketoconazole tablet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Pain, Low Back Pain
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
- Trial name
- NCT01256450
- Testing
- Buprenorphine
- Where
- 24 sites in United States
- Volunteers
- 334 people
- Sponsor
- BioDelivery Sciences International
Osteoarthritis
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe…
- Trial name
- NCT00313846
- Testing
- Buprenorphine transdermal patch
- Where
- 44 sites in United States
- Volunteers
- 529 people
- Sponsor
- Purdue Pharma LP
Back Pain Lower Back Chronic
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in…
- Trial name
- NCT00313014
- Testing
- Buprenorphine, Oxycodone Immediate-Release
- Where
- 85 sites in United States
- Volunteers
- 660 people
- Sponsor
- Purdue Pharma LP
Back Pain
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back…
- Trial name
- BP96-0604 (NCT00315445)
- Testing
- Buprenorphine transdermal patch, OXY/APAP
- Where
- 12 sites in United States
- Volunteers
- 134 people
- Sponsor
- Purdue Pharma LP
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
Opioid-use Disorder
SUBLOCADE Rapid Initiation Study
This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.
- Trial name
- NCT03993392
- Testing
- TM buprenorphine, SUBLOCADE
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Indivior Inc.
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
Pain
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
- Trial name
- NCT01324570
- Testing
- Buprenorphine transdermal system
- Where
- 22 sites in United States
- Volunteers
- 41 people
- Sponsor
- Purdue Pharma LP
Healthy Volunteers
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
- Trial name
- NCT01148537
- Testing
- Buprenorphine transdermal patch, Avelox (moxifloxacin hydrochloride) tablet
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Low Back Pain
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous…
- Trial name
- NCT01675167
- Testing
- Buprenorphine
- Where
- 66 sites in United States
- Volunteers
- 815 people
- Sponsor
- BioDelivery Sciences International