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

Information source: International Clinical Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuropathic Pain

Intervention: Hydromorphone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: International Clinical Research Institute

Official(s) and/or principal investigator(s):
Srinivas Nalamachu, MD, Principal Investigator, Affiliation: International Clinical Research Institute

Summary

The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.

Clinical Details

Official title: Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale

Secondary outcome:

Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours

Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours

Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now

Sleep Quality Assessment (SQA)

Pain Quality Assessment Scale (PQAS)

Global Assessment of Treatment Satisfaction

Detailed description: Neuropathic pain state is usually refractory to most analgesic regimens and requires polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include both oral and topical medications. Most commonly prescribed oral treatments include antidepressants (eg, amitriptyline, desipramine, and duloxetine), antiepileptics (eg, gabapentin, pregabalin), and opiates such as tramadol and morphine. Current topical treatments include the lidocaine patch and the capsaicin patch. Many patients have inadequate pain relief in spite of these treatment options. Currently, there are no treatments available for treatment of neuropathy itself other than treating the underlying cause and addressing the symptomatic relief for pain. Current drug therapies for neuropathic pain provide inadequate pain relief and undesirable side effects including sedation and cognitive dysfunction. It is not uncommon to use a combination of agents for the treatment of neuropathic pain to minimize the side effects. Although treating the mild to moderate pain may be relatively easy, it is very challenging for severe neuropathic pain. Although the use of opiates for neuropathic pain is well accepted, it remains controversial because of the potential for abuse and diversion.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. individuals with chronic pain of more than 6 months duration 2. pain is determined to be secondary to a documented neuropathy 3. patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week) 4. male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement 5. female patients of child-bearing potential must be using an acceptable form of birth control Exclusion Criteria: 1. pregnant or lactating women 2. allergy to morphine or its derivatives 3. history of alcohol or substance abuse in the last 3 yrs 4. participation in any other clinical trial in the last 30 days 5. uncontrolled pain 6. patient who is deemed to be medically unstable by principal investigator 7. history of severe lung disease or asthma that is deemed medically significant by principal investigator

Locations and Contacts

International Clinical Research Institute, Leawood, Kansas 66211, United States
Additional Information

Starting date: September 2010
Last updated: May 17, 2012

Page last updated: August 23, 2015

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