Clinical trials: Opioids
Healthy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Acute Pain
A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery
This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients…
- Trial name
- NCT01789476
- Testing
- CR845
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Cara Therapeutics, Inc.
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Pain, Cancer
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy.
- Trial name
- NCT00293020
- Testing
- BEMA Fentanyl
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BioDelivery Sciences International
Chronic Pain
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours.
- Trial name
- NCT00765856
- Testing
- Oxymorphone ER
- Where
- 13 sites in United States
- Volunteers
- 27 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Postherpetic Neuralgia
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN).
- Trial name
- NCT01058642
- Testing
- ADL5747, Pregabalin
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Pain
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant…
- Trial name
- NCT01192295
- Testing
- Oxycodone HCl controlled-release tablets
- Where
- 47 sites in United States, Greece and 6 more
- Volunteers
- 155 people
- Sponsor
- Purdue Pharma LP
Chronic Pain
Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time
The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by…
- Trial name
- NCT01240863
- Testing
- Hydrocodone ER
- Where
- 73 sites in United States
- Volunteers
- 391 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Analgesia Disorder, Pain
A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management
This is a randomized, double blind, placebo-controlled, single dose study to assess the safety and efficacy of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.
- Trial name
- NCT02468128
- Testing
- Sebacoyl Dinalbuphine Ester
- Where
- 6 sites in Taiwan
- Volunteers
- 221 people
- Sponsor
- Lumosa Therapeutics Co., Ltd.
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.
Opioid-Induced Constipation
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness…
- Trial name
- NCT00672139
- Testing
- Methylnaltrexone bromide
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Bausch Health Americas, Inc.
Pain
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.
- Trial name
- ACCESS 2008 (NCT00640042)
- Testing
- morphine sulfate extended release capsules
- Where
- 384 sites in United States, Puerto Rico
- Volunteers
- 1,570 people
- Sponsor
- Pfizer
Opioid-induced Constipation
Compassionate Use Study of Methylnaltrexone
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
- Trial name
- NCT01368562
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-induced Constipation
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
- Trial name
- NCT01443403
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 244 people
- Sponsor
- Shionogi
Opioid-induced Constipation
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
- Trial name
- NCT01993940
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 553 people
- Sponsor
- Shionogi
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
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
- Trial name
- NCT00605033
- Testing
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
- Volunteers
- 241 people
- Sponsor
- Indivior Inc.
Postoperative Pain
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03295721
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 15 sites in United States
- Volunteers
- 412 people
- Sponsor
- Heron Therapeutics
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
Opioid-Induced Constipation (OIC)
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
- Trial name
- NCT01395524
- Testing
- NKTR-118
- Where
- 116 sites in United States, Australia and 2 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca