Clinical trial NCT01207596: Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Official title: Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Keywords: Pain
Neuropathy
Neuropathic Pain
Hydromorphone
Lead sponsor: International Clinical Research Institute
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale
timeFrame: Baseline visit to Week 12 or last visit
Secondary outcomes:
measure: 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
timeFrame: Baseline visit to Week 12 or last visit
measure: 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
timeFrame: Baseline visit to Week 12 or last visit
measure: 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
timeFrame: Baseline visit to Week 12 or last visit
measure: Sleep Quality Assessment (SQA)
timeFrame: Baseline visit to Week 12 or last visit
measure: Pain Quality Assessment Scale (PQAS)
timeFrame: Baseline visit to 12 weeks visit
measure: Global Assessment of Treatment Satisfaction
timeFrame: Baseline visit to Week 12 or last visit
Other outcomes:
Locations:
city: Leawood
country: United States
facility: International Clinical Research Institute
state: Kansas
Study officials:
affiliation: International Clinical Research Institute
name: Srinivas Nalamachu, MD
role: PRINCIPAL_INVESTIGATOR
References: