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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

An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg

Phase 1
Completed
Conditions
Analgesia
First Posted Date
2006-11-14
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
32
Registration Number
NCT00398957

An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)

Phase 3
Completed
Conditions
Osteoarthritis, Knee
Osteoarthritis, Hip
First Posted Date
2006-11-14
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
140
Registration Number
NCT00399048

An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg

Phase 1
Completed
Conditions
Analgesia
First Posted Date
2006-11-14
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
30
Registration Number
NCT00399295

A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain

Phase 2
Completed
Conditions
Low Back Pain
First Posted Date
2006-11-14
Last Posted Date
2010-04-27
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
207
Registration Number
NCT00398788

Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

Phase 4
Completed
Conditions
Post Operative Pain
Interventions
First Posted Date
2006-10-09
Last Posted Date
2018-08-14
Lead Sponsor
Columbia University
Target Recruit Count
50
Registration Number
NCT00385541
Locations
🇺🇸

Columbia Presbyterian Hospital, New York, New York, United States

Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

Phase 3
Terminated
Conditions
Chronic Non-Malignant Pain
First Posted Date
2006-08-18
Last Posted Date
2006-08-18
Lead Sponsor
Purdue Pharma LP
Target Recruit Count
380
Registration Number
NCT00365898
Locations
🇺🇸

Clinical Research of West Florida, Inc. 2147 NE Coachman Road, Clearwater, Florida, United States

🇺🇸

PharmQuest 301 E Wendover Avenue Suite 411, Greensboro, North Carolina, United States

🇺🇸

Arizona Research Center 2525 W. Greenway Rd. Suite 114, Phoenix, Arizona, United States

and more 11 locations

Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain

Phase 2
Completed
Conditions
Acute Pain
Interventions
First Posted Date
2006-03-21
Last Posted Date
2018-08-20
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
298
Registration Number
NCT00305110
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain

Phase 2
Completed
Conditions
Acute Pain
Interventions
First Posted Date
2006-03-21
Last Posted Date
2018-08-20
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
194
Registration Number
NCT00305058
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer

Completed
Conditions
Fallopian Tube Cancer
Pain
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Perioperative/Postoperative Complications
Sarcoma
Interventions
First Posted Date
2006-02-24
Last Posted Date
2014-05-20
Lead Sponsor
University of California, San Francisco
Target Recruit Count
240
Registration Number
NCT00295945
Locations
🇺🇸

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

Phase 3
Completed
Conditions
Pain
Interventions
First Posted Date
2005-12-05
Last Posted Date
2014-06-03
Lead Sponsor
Janssen Pharmaceutica N.V., Belgium
Target Recruit Count
504
Registration Number
NCT00261495
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