CLINICAL TRIALS PROFILE FOR EXALGO

All Clinical Trials for Exalgo

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01207596 ↗	Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain	Completed	International Clinical Research Institute	Phase 4	2010-09-01	The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
NCT01455519 ↗	True Functional Restoration and Analgesia in Non-Radicular Low Back Pain	Completed	Mallinckrodt	Phase 4	2011-10-01	You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
NCT01455519 ↗	True Functional Restoration and Analgesia in Non-Radicular Low Back Pain	Completed	Rehabilitation Institute of Chicago	Phase 4	2011-10-01	You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
NCT01455519 ↗	True Functional Restoration and Analgesia in Non-Radicular Low Back Pain	Completed	Shirley Ryan AbilityLab	Phase 4	2011-10-01	You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
NCT01517295 ↗	Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients	Completed	International Clinical Research Institute	Phase 4	2012-02-01	Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
NCT01517295 ↗	Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients	Completed	Medtronic - MITG	Phase 4	2012-02-01	Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.

Clinical Trial Conditions for Exalgo

Condition Name

Condition Name for Exalgo
Intervention	Trials
Pain	2
Intraoperative Complication	1
Liver and Intrahepatic Bile Duct Disorder	1
Low Back Pain	1

Condition MeSH

Condition MeSH for Exalgo
Intervention	Trials
Chronic Pain	1
Liver Diseases	1
Low Back Pain	1
Bile Duct Diseases	1

Clinical Trial Locations for Exalgo

Trials by Country

Trials by Country for Exalgo
Location	Trials
United States	10

Trials by US State

Trials by US State for Exalgo
Location	Trials
Texas	2
Kansas	2
California	1
Wisconsin	1
Ohio	1

Clinical Trial Progress for Exalgo

Clinical Trial Phase

Clinical Trial Phase for Exalgo
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for Exalgo
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for Exalgo

Sponsor Name

Sponsor Name for Exalgo
Sponsor	Trials
National Cancer Institute (NCI)	3
International Clinical Research Institute	2
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for Exalgo
Sponsor	Trials
Other	11
NIH	5
Industry	3