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Last Updated: November 12, 2019

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CLINICAL TRIALS PROFILE FOR HYDROMORPHONE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Hydromorphone 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 NCT00245375 A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00245375 A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed Nova Scotia Health Authority N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
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 Hydromorphone Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003115 Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy Completed Roswell Park Cancer Institute Phase 3 1996-06-01 RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer surgery. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical prostatectomy.
NCT00125801 The Pain Pen for Breakthrough Cancer Pain Terminated Erasmus Medical Center Phase 3 2005-08-01 The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.
NCT00134875 Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers Terminated National Institute of Allergy and Infectious Diseases (NIAID) N/A 2000-12-01 Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals. However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in non-dependent opioid abusers.
NCT00134888 Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence Completed National Institute on Drug Abuse (NIDA) N/A 2000-12-01 Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.
NCT00134914 Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence Completed National Institute on Drug Abuse (NIDA) N/A 1996-08-01 Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.
NCT00158236 Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users Completed National Institute on Drug Abuse (NIDA) N/A 1997-01-01 Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.
NCT00163553 Neuraxial Pethidine After Lumbar Surgery Trial Unknown status Austin Health Phase 3 2004-12-01 The hypothesis is that epidural pethidine is an effective form of pain relief following lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered (intravenous) patient-controlled analgesia (PCA) pethidine.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydromorphone Hydrochloride

Condition Name

Condition Name for Hydromorphone Hydrochloride
Intervention Trials
Pain 56
Postoperative Pain 18
Acute Pain 16
Pain, Postoperative 15
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Condition MeSH

Condition MeSH for Hydromorphone Hydrochloride
Intervention Trials
Pain, Postoperative 43
Acute Pain 23
Opioid-Related Disorders 11
Chronic Pain 10
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Clinical Trial Locations for Hydromorphone Hydrochloride

Trials by Country

Trials by Country for Hydromorphone Hydrochloride
Location Trials
United States 186
Canada 27
Germany 6
Poland 4
China 4
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Trials by US State

Trials by US State for Hydromorphone Hydrochloride
Location Trials
New York 32
Illinois 17
Texas 13
California 12
Ohio 10
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Clinical Trial Progress for Hydromorphone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Hydromorphone Hydrochloride
Clinical Trial Phase Trials
Phase 4 90
Phase 3 44
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Hydromorphone Hydrochloride
Clinical Trial Phase Trials
Completed 93
Recruiting 53
Not yet recruiting 35
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Clinical Trial Sponsors for Hydromorphone Hydrochloride

Sponsor Name

Sponsor Name for Hydromorphone Hydrochloride
Sponsor Trials
Montefiore Medical Center 16
Alza Corporation, DE, USA 14
National Institute on Drug Abuse (NIDA) 12
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Sponsor Type

Sponsor Type for Hydromorphone Hydrochloride
Sponsor Trials
Other 201
Industry 70
NIH 16
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