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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Clinical Research Institute
• Treatments: Hydromorphone

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