Clinical trials: Non-malignant Pain
Pain
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe…
- Trial name
- NCT01369615
- Testing
- Oxycodone hydrochloride controlled-release tablets
- Where
- 14 sites in United States, Israel
- Volunteers
- 23 people
- Sponsor
- Purdue Pharma LP
Chronic Non-malignant Pain
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant…
- Trial name
- NCT00312195
- Testing
- Buprenorphine transdermal patch
- Where
- 42 sites in United States, United Kingdom
- Volunteers
- 267 people
- Sponsor
- Purdue Pharma LP
Chronic Pain
Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain
The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.
- Trial name
- NCT00225797
- Testing
- Oxymorphone Extended Release
- Where
- 33 sites in United States
- Volunteers
- 160 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Chronic Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
- Trial name
- NCT01206907
- Testing
- oxymorphone IR
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Constipation
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.
- Trial name
- NCT00366431
- Testing
- MOA-728
- Where
- 67 sites in United States
- Volunteers
- 420 people
- Sponsor
- Bausch Health Americas, Inc.
Constipation
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with…
- Trial name
- NCT00804141
- Testing
- N-methylnaltrexone bromide (MOA-728)
- Where
- 120 sites in United States, Australia and 4 more
- Volunteers
- 1,040 people
- Sponsor
- Bausch Health Americas, Inc.
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
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
Chronic Nonmalignant and Nonneuropathic Pain
Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
- Trial name
- NCT01400139
- Testing
- Hydrocodone bitartrate q24h film-coated tablets
- Where
- 98 sites in United States
- Volunteers
- 922 people
- Sponsor
- Purdue Pharma LP
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
Pain
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
- Trial name
- NCT00412100
- Testing
- Oxycodone naloxone prolonged release tablets (OXN)
- Sponsor
- Mundipharma Research GmbH & Co KG
Opioid-Induced Constipation
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in…
- Trial name
- NCT01186770
- Testing
- Methylnaltrexone
- Where
- 2 sites in United States
- Volunteers
- 804 people
- Sponsor
- Bausch Health Americas, Inc.
Chronic Nonmalignant Pain
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously…
- Trial name
- NCT01151098
- Testing
- Buprenorphine transdermal patch
- Where
- 19 sites in United States
- Volunteers
- 189 people
- Sponsor
- Purdue Pharma LP
Chronic, Non Malignant Pain
Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled.
- Trial name
- NCT00485225
- Testing
- EN3270
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Durect
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Constipation
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
- Trial name
- OIC (NCT01983306)
- Testing
- SP-333 1 mg, SP-333 3 mg, SP-333 6 mg
- Where
- 42 sites in United States
- Volunteers
- 292 people
- Sponsor
- Bausch Health Americas, Inc.
Pain
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.
- Trial name
- NCT02542098
- Testing
- HYD tablets
- Sponsor
- Purdue Pharma LP
Pain
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of non-malignant chronic pain.
- Trial name
- NCT00126763
- Testing
- Fentanyl Transdermal Matrix Patch ZR-02-01
- Where
- 6 sites in United States
- Volunteers
- 105 people
- Sponsor
- ZARS Pharma Inc.
Opioid-induced Constipation
Long Term Safety of Naldemedine
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
- Trial name
- NCT01965652
- Testing
- Naldemedine
- Where
- 186 sites in United States, Australia and 14 more
- Volunteers
- 1,246 people
- Sponsor
- Shionogi
Pain, Analgesics
A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal…
- Conditions
- Pain, Analgesics, Opioid
- Trial name
- NCT00410644
- Testing
- OROS Hydromorphone HCI
- Volunteers
- 463 people
- Sponsor
- Alza Corporation, DE, USA