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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR OXYMORPHONE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Oxymorphone Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02929589 Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy Not yet recruiting Mike O'Callaghan Federal Hospital N/A 2017-04-01 This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Oxymorphone Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00225797 Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain Completed Endo Pharmaceuticals Phase 3 2004-11-01 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.
NCT00226395 Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain Completed Endo Pharmaceuticals Phase 3 2004-09-01 The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
NCT00226421 Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain Completed Endo Pharmaceuticals Phase 3 2004-10-01 The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.
NCT00260260 OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain Completed Odense University Hospital Phase 4 2005-06-01 Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there is insufficient pain relief with oxycodone. Patients' pain and side effects will be registered and after 24 hours they will answer a questionnaire. All included patients will be genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and measures of plasma levels of oxycodone will be performed.
NCT00271973 OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models Completed Odense University Hospital Phase 4 2006-02-01 Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme with normal function. The study hypothesis is that PM will experience less pain relief than EM.
NCT00580294 A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) Completed Endo Pharmaceuticals N/A 2007-11-01 The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.
NCT00580294 A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) Completed Icahn School of Medicine at Mount Sinai N/A 2007-11-01 The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Oxymorphone Hydrochloride

Condition Name

Condition Name for Oxymorphone Hydrochloride
Intervention Trials
Pain 9
Chronic Pain 6
Neuropathic Pain 2
Acute Pain 2
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Condition MeSH

Condition MeSH for Oxymorphone Hydrochloride
Intervention Trials
Chronic Pain 7
Pain, Postoperative 6
Acute Pain 2
Neuralgia 2
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Clinical Trial Locations for Oxymorphone Hydrochloride

Trials by Country

Trials by Country for Oxymorphone Hydrochloride
Location Trials
United States 97
Denmark 2
Canada 1
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Trials by US State

Trials by US State for Oxymorphone Hydrochloride
Location Trials
Texas 9
North Carolina 7
Pennsylvania 7
Florida 6
Colorado 5
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Clinical Trial Progress for Oxymorphone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Oxymorphone Hydrochloride
Clinical Trial Phase Trials
Phase 4 7
Phase 3 13
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Oxymorphone Hydrochloride
Clinical Trial Phase Trials
Completed 17
Not yet recruiting 4
Recruiting 4
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Clinical Trial Sponsors for Oxymorphone Hydrochloride

Sponsor Name

Sponsor Name for Oxymorphone Hydrochloride
Sponsor Trials
Endo Pharmaceuticals 17
Odense University Hospital 2
Sandoz 2
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Sponsor Type

Sponsor Type for Oxymorphone Hydrochloride
Sponsor Trials
Industry 22
Other 11
NIH 1
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