Neuropathic Pain Clinical Trial
Official title:
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | International Clinical Research Institute | Leawood | Kansas |
Lead Sponsor | Collaborator |
---|---|
International Clinical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale | The primary efficacy measure was the change from baseline to end of study on question #5 ("average pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain on the average," where 0 = no pain and 10 = pain as bad as you can imagine. | Baseline visit to Week 12 or last visit | No |
Secondary | 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 to end of study on question #3 ("worst pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours," where 0 = no pain and 10 = pain as bad as you can imagine. | Baseline visit to Week 12 or last visit | No |
Secondary | 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 to end of study on question #4 ("least pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours," where 0 = no pain and 10 = pain as bad as you can imagine. | Baseline visit to Week 12 or last visit | No |
Secondary | 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 | Change from baseline to end of study on question #4 ("current pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that tells how much pain you have right now," where 0 = no pain and 10 = pain as bad as you can imagine. | Baseline visit to Week 12 or last visit | No |
Secondary | Sleep Quality Assessment (SQA) | Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes) | Baseline visit to Week 12 or last visit | No |
Secondary | Pain Quality Assessment Scale (PQAS) | The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain | Baseline visit to 12 weeks visit | No |
Secondary | Global Assessment of Treatment Satisfaction | Patients were asked to rate their global assessment of treatment satisfaction, ranging from "very dissatisfied" to "very satisfied". Adverse events were monitored throughout the study | Baseline visit to Week 12 or last visit | No |
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