Neuropathic PainPhase 4NCT01207596
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
A Phase 4 study testing Hydromorphone in people with Neuropathic Pain, run by International Clinical Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Hydromorphone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
International Clinical Research Institute
Leawood, Kansas, 66211
About this study
Official title: Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Hydromorphone
- Keywords
- Pain, Neuropathy, Neuropathic Pain, Hydromorphone
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called EXALGO (R)
Oral hydromorphone extended release, once daily
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Active comparator | Not described Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit to Week 12 or last visit
Secondary outcomes (6)
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.
Measured: Baseline visit to Week 12 or last visit
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.
Measured: Baseline visit to Week 12 or last visit
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.
Measured: Baseline visit to Week 12 or last visit
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)
Measured: Baseline visit to Week 12 or last visit
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
Measured: Baseline visit to 12 weeks visit
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
Measured: Baseline visit to Week 12 or last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Clinical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivas Nalamachu, International Clinical Research Institute
- Investigators
- Srinivas Nalamachu, MD, Principal investigator, International Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207596
- Sponsor's protocol ID
- EX-NP2010
- Status last verified
- May 2012
- First submitted
- 20 Sep 2010
- Last updated
- 20 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study
- ClinicalTrials.gov ID
- NCT01207596
- Acronym / sponsor ID
- EX-NP2010
- Conditions
- Neuropathic Pain
- Keywords
- Pain, Neuropathy, Neuropathic Pain, Hydromorphone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- International Clinical Research InstituteUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Active comparator | Drug: Hydromorphone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneAlso: EXALGO (R)Oral hydromorphone extended release, once daily | Drug | Hydromorphone |
Primary outcome
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
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.
6 secondary outcomes
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
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
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
Sleep Quality Assessment (SQA)
Time frame: Baseline visit to Week 12 or last visit
Pain Quality Assessment Scale (PQAS)
Time frame: Baseline visit to 12 weeks visit
Global Assessment of Treatment Satisfaction
Time frame: Baseline visit to Week 12 or last visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas Nalamachu, MD principal investigator
International Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone in people with Neuropathic Pain, run by International Clinical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.