Neuropathic Pain
Conditions
Keywords
Pain, Neuropathy, Neuropathic Pain, Hydromorphone
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 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.
Interventions
DRUGHydromorphone
Oral hydromorphone extended release, once daily
Sponsors
International Clinical Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale | Baseline visit to Week 12 or last visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline visit to Week 12 or last visit | 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. |
| 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 | Baseline visit to Week 12 or last visit | 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. |
| 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 | Baseline visit to Week 12 or last visit | 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. |
| Pain Quality Assessment Scale (PQAS) | Baseline visit to 12 weeks visit | 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 |
| Global Assessment of Treatment Satisfaction | Baseline visit to Week 12 or last visit | 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 |
| Sleep Quality Assessment (SQA) | Baseline visit to Week 12 or last visit | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Hydromorphone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Baseline visit to Week 12 or last visit
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydromorphone | 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 | Standard Error 0.55 |
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.
Time frame: Baseline visit to Week 12 or last visit
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydromorphone | 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 units on a scale | Standard Deviation 0.61 |
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.
Time frame: Baseline visit to Week 12 or last visit
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydromorphone | 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 units on a scale | Standard Deviation 0.57 |
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.
Time frame: Baseline visit to Week 12 or last visit
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydromorphone | 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 units on a scale | Standard Error 0.59 |
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
Time frame: Baseline visit to Week 12 or last visit
Population: LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone | Global Assessment of Treatment Satisfaction | Very satisfied | 38.5 percentage of patients |
| Hydromorphone | Global Assessment of Treatment Satisfaction | Satisfied | 42.3 percentage of patients |
| Hydromorphone | Global Assessment of Treatment Satisfaction | Dissatisfied | 15.4 percentage of patients |
| Hydromorphone | Global Assessment of Treatment Satisfaction | Very dissatisfied | 3.8 percentage of patients |
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
Time frame: Baseline visit to 12 weeks visit
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydromorphone | Pain Quality Assessment Scale (PQAS) | -24.8 units on a scale | Standard Error 7.9 |
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)
Time frame: Baseline visit to Week 12 or last visit
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydromorphone | Sleep Quality Assessment (SQA) | -1.7 units on a scale | Standard Deviation 0.6 |