Phase 4
N=30
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01207596 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale — -1.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- International Clinical Research Institute
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale |
-1.2 | — |
| 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 |
-1.8 | — |
| 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 |
-0.9 | — |
| 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 |
-1.3 | — |
| SECONDARY Sleep Quality Assessment (SQA) |
-1.7 | — |
| SECONDARY Pain Quality Assessment Scale (PQAS) |
-24.8 | — |
| SECONDARY Global Assessment of Treatment Satisfaction |
38.5; 42.3; 15.4; 3.8 | — |
Summary
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01207596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.