Status:
COMPLETED
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Lead Sponsor:
International Clinical Research Institute
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
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 m...
Eligibility Criteria
Inclusion
- individuals with chronic pain of more than 6 months duration
- pain is determined to be secondary to a documented neuropathy
- patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week)
- male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement
- female patients of child-bearing potential must be using an acceptable form of birth control
Exclusion
- pregnant or lactating women
- allergy to morphine or its derivatives
- history of alcohol or substance abuse in the last 3 yrs
- participation in any other clinical trial in the last 30 days
- uncontrolled pain
- patient who is deemed to be medically unstable by principal investigator
- history of severe lung disease or asthma that is deemed medically significant by principal investigator
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01207596
Start Date
September 1 2010
End Date
September 1 2011
Last Update
June 20 2012
Active Locations (1)
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1
International Clinical Research Institute
Leawood, Kansas, United States, 66211