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

Phase 4

Completed

Conditions: Neuropathic Pain

Interventions: Drug: Hydromorphone

Registration Number: NCT01207596

Lead Sponsor: International Clinical Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydromorphone	Hydromorphone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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)
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