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Hydromorphone

Generic Name
Hydromorphone
Brand Names
Dilaudid, Exalgo, Hydromorph Contin, Hydromorphone Hp Forte
Drug Type
Small Molecule
Chemical Formula
C17H19NO3
CAS Number
466-99-9
Unique Ingredient Identifier
Q812464R06
Background

Hydromorphone is a pure opioid, a semi-synthetic hydrogenated ketone derivative of morphine that has been available clinically since 1920. Structurally, hydromorphone derived from morphine in the modification of the hydroxyl group in the carbon 6 to a carbonyl and the absence of a double bond between the carbon 7 and 8. Due to these modifications, it presents a very high potency and comparable side effect profile to the parent compound. Even though hydromorphone does not present a 6-hydroxyl group, it is categorized under the family of phenanthrenes and it is considered a chemical under the schedule II (medical purposes with high addiction potential).

The first reported approved product containing hydromorphone in the form of hydromorphone hydrochloride was developed by Fresenius Kabi USA and FDA approved in 1984.

Indication

Hydromorphone is indicated for the management of moderate to severe acute pain and severe chronic pain. Due to its addictive potential and overdose risk, hydromorphone is only prescribed when other first-line treatments have failed.

The WHO has proposed a three-step ladder for the management of pain in which it is suggested to start with a non-opioid medication followed by addition of weak opioids to the non-opioid treatment for moderate pain and finishing in the use of strong opioids such as hydromorphone along with the existing regimen for cases of severe pain.

Off-label, hydromorphone can be administered for the suppression of refractory cough.

Associated Conditions
Neuropathic Pain, Refractory Chronic Cough, Moderate to severe pain

Protocolized vs Discretionary Use of Opioids in Acute Pain

Phase 3
Completed
Conditions
Pain
Interventions
Drug: IV opioid
First Posted Date
2009-01-21
Last Posted Date
2018-06-12
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
350
Registration Number
NCT00825370
Locations
🇺🇸

Montefiore Medical Center Emergency Department, Bronx, New York, United States

An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain

Phase 4
Completed
Conditions
Cancer Pain
Interventions
First Posted Date
2008-10-06
Last Posted Date
2013-10-23
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
190
Registration Number
NCT00766831

Intravenous Remifentanil for Labor Analgesia

Phase 4
Completed
Conditions
Labor Pain
Interventions
First Posted Date
2008-07-04
Last Posted Date
2009-09-18
Lead Sponsor
Nanjing Medical University
Target Recruit Count
1000
Registration Number
NCT00710086
Locations
🇨🇳

Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China

Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients

Phase 4
Completed
Conditions
Pain
Interventions
First Posted Date
2008-05-22
Last Posted Date
2018-08-13
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
230
Registration Number
NCT00682435
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Not Applicable
Completed
Conditions
Low Back Pain
Interventions
First Posted Date
2008-03-26
Last Posted Date
2013-02-13
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
32
Registration Number
NCT00644111
Locations
🇨🇦

Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada

A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

Phase 3
Completed
Conditions
Chronic Pain
Interventions
First Posted Date
2008-03-07
Last Posted Date
2020-09-16
Lead Sponsor
Mallinckrodt
Target Recruit Count
343
Registration Number
NCT00631319

Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain

Phase 3
Completed
Conditions
Acute Pain
Interventions
Drug: Nonprotocolized
First Posted Date
2008-03-03
Last Posted Date
2018-04-05
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
224
Registration Number
NCT00627367
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain

Phase 3
Completed
Conditions
Chronic Low Back Pain
Interventions
First Posted Date
2007-10-25
Last Posted Date
2020-06-17
Lead Sponsor
Mallinckrodt
Target Recruit Count
459
Registration Number
NCT00549042

The Discriminative Effects of Tramadol in Humans

Phase 1
Completed
Conditions
Stimulant Abuse
Stimulant Addiction
Opioid Abuse
Opioid Addiction
Interventions
First Posted Date
2007-07-11
Last Posted Date
2017-10-17
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Target Recruit Count
20
Registration Number
NCT00499746
Locations
🇺🇸

Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

Phase 4
Completed
Conditions
Postoperative Pain
Interventions
First Posted Date
2007-04-25
Last Posted Date
2015-11-18
Lead Sponsor
Purdue Pharma LP
Target Recruit Count
116
Registration Number
NCT00465647
Locations
🇺🇸

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

🇺🇸

Children's Hospital of Orange County - Pediatric Subspecialty, Orange, California, United States

🇺🇸

Stanford University Medical Center, Stanford, California, United States

and more 11 locations
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