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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Srinivas Nalamachu, International Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT01207596
First received: September 20, 2010
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.


Condition Intervention Phase
Neuropathic Pain
Drug: Hydromorphone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study

Resource links provided by NLM:


Further study details as provided by International Clinical Research Institute:

Primary Outcome Measures:
  • Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale [ Time Frame: Baseline visit to Week 12 or last visit ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: Baseline visit to Week 12 or last visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline visit to Week 12 or last visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline visit to Week 12 or last visit ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline visit to Week 12 or last visit ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline visit to 12 weeks visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline visit to Week 12 or last visit ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydromorphone Drug: Hydromorphone
Oral hydromorphone extended release, once daily
Other Name: EXALGO (R)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207596

Locations
United States, Kansas
International Clinical Research Institute
Leawood, Kansas, United States, 66211
Sponsors and Collaborators
International Clinical Research Institute
Investigators
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute
  More Information

No publications provided

Responsible Party: Srinivas Nalamachu, MD, International Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01207596     History of Changes
Other Study ID Numbers: EX-NP2010
Study First Received: September 20, 2010
Results First Received: October 4, 2011
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by International Clinical Research Institute:
Pain
Neuropathy
Neuropathic Pain
Hydromorphone

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014