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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

ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

Phase 2
Completed
Conditions
Opiate Dependence
Interventions
Drug: Medisorb naltrexone 75 mg
Drug: Medisorb naltrexone 150 mg
Drug: Medisorb naltrexone 300 mg
First Posted Date
2010-10-13
Last Posted Date
2017-01-11
Lead Sponsor
Alkermes, Inc.
Target Recruit Count
27
Registration Number
NCT01218984

Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain

Phase 4
Completed
Conditions
Neuropathic Pain
Interventions
First Posted Date
2010-09-23
Last Posted Date
2012-06-20
Lead Sponsor
International Clinical Research Institute
Target Recruit Count
30
Registration Number
NCT01207596
Locations
🇺🇸

International Clinical Research Institute, Leawood, Kansas, United States

An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

Phase 3
Completed
Conditions
Pain
Interventions
First Posted Date
2010-09-20
Last Posted Date
2014-02-03
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
260
Registration Number
NCT01205126

The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

Not Applicable
Completed
Conditions
Visual Analog Pain Scale
Pain Measurement
Interventions
First Posted Date
2010-07-30
Last Posted Date
2011-06-27
Lead Sponsor
Korea University Anam Hospital
Target Recruit Count
60
Registration Number
NCT01172782

Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint

Not Applicable
Withdrawn
Conditions
Ventilatory Depression
Pain
Interventions
First Posted Date
2010-05-14
Last Posted Date
2015-04-22
Lead Sponsor
Northwestern University
Registration Number
NCT01123486
Locations
🇺🇸

Northwestern Memorial Hospital, Chicago, Illinois, United States

An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

Phase 4
Completed
Conditions
Cancer
Pain
Interventions
First Posted Date
2009-11-01
Last Posted Date
2013-08-08
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
141
Registration Number
NCT01006356

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

Phase 2
Completed
Conditions
Constipation
First Posted Date
2009-10-09
Last Posted Date
2012-02-15
Lead Sponsor
Mundipharma Research GmbH & Co KG
Target Recruit Count
600
Registration Number
NCT00992576
Locations
🇨🇭

Kantonsspital Aarau, Aarau, Switzerland

🇦🇺

Hunter New England Area Health Service, Newcastle, New South Wales, Australia

🇧🇪

Erasme Hospital, Bruxelles, Belgium

and more 11 locations

Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

Phase 3
Completed
Conditions
Pain
Osteoarthritis, Hip
Osteoarthritis, Knee
Interventions
First Posted Date
2009-09-21
Last Posted Date
2014-04-25
Lead Sponsor
Janssen-Cilag International NV
Target Recruit Count
288
Registration Number
NCT00980798

Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-08-07
Last Posted Date
2017-10-05
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
78
Registration Number
NCT00955110

Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets

First Posted Date
2009-03-02
Last Posted Date
2016-10-19
Lead Sponsor
Mallinckrodt
Target Recruit Count
24
Registration Number
NCT00853554
Locations
🇺🇸

Gateway Medical Research, St. Charles, Missouri, United States

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