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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

A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain

Phase 2
Completed
Conditions
Pain, Postoperative
Orthopedic Procedures
Analgesia
First Posted Date
2006-12-14
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
50
Registration Number
NCT00411307

Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)

Phase 3
Completed
Conditions
Pain
Analgesics, Opioid
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
388
Registration Number
NCT00410748

A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.

Phase 3
Completed
Conditions
Pain
Analgesics, Opioid
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
202
Registration Number
NCT00410540

Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

Phase 3
Completed
Conditions
Low Back Pain
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
207
Registration Number
NCT00411268

A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain

Phase 3
Completed
Conditions
Analgesics, Opioid
Pain
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
463
Registration Number
NCT00411034

A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain

Phase 3
Completed
Conditions
Pain
Analgesics
Opioid
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
463
Registration Number
NCT00410644

Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain

Phase 3
Completed
Conditions
Pain
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
169
Registration Number
NCT00410943

Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain

Phase 3
Completed
Conditions
Analgesics, Opioid
Pain
First Posted Date
2006-12-13
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
68
Registration Number
NCT00410787

A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis

Phase 3
Completed
Conditions
Osteoarthritis, Knee
Osteoarthritis, Hip
First Posted Date
2006-12-13
Last Posted Date
2013-07-08
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
990
Registration Number
NCT00411164

A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain

Phase 1
Completed
Conditions
Pain
Analgesics, Opioid
First Posted Date
2006-12-13
Last Posted Date
2017-02-17
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
22
Registration Number
NCT00410878
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