Peripheral NeuropathyNCT00181246
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
A study testing Transdermal Fentanyl in people with Peripheral Neuropathy and Complex Regional Pain Syndromes (CRPS), run by Johns Hopkins University.
Trial summary
The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy, Complex Regional Pain Syndromes (CRPS)
- What is being tested?
- Transdermal Fentanyl
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age >18 years
- Neuropathic pain persisting for > 3 months
- Pain over the immediate previous three months
- The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment
Who cannot join
- A history of substance abuse
- Allergic reaction to an opioid
- Significant pain of alternate etiology other than the neuropathic pain state
- Severe pulmonary disease
- Recent myocardial infarction (within the preceding three months)
- Pregnancy
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- Dementia
- Encephalopathy
- Those with life expectancy of less than six months and HIV seropositivity.
About this study
The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.
- Being tested
- Transdermal Fentanyl
- Keywords
- Neuropathic pain, Efficacy
- Medical subject headings
- Peripheral Nervous System Diseases, Complex Regional Pain Syndromes, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal FentanylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (0-10) and daily activity
Secondary outcomes (3)
Pain relief (0-100%)
Cognition (digital symbol and grooved peg-board)
Impairment of function (MPI) and affect (BDI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Responsible party
- Sponsor
- Investigators
- Srinivasa N Raja, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181246
- Sponsor's protocol ID
- 20021288
- Status last verified
- Aug 2017
- First submitted
- 14 Sep 2005
- Last updated
- 24 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00181246
- Acronym / sponsor ID
- 20021288
- Keywords
- Neuropathic pain, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Oct 2003
- Study completion
- Sep 2005
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Neuropathic pain persisting for > 3 months
- Pain over the immediate previous three months
- The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment
Key exclusion criteria (9 listed)
- A history of substance abuse
- Allergic reaction to an opioid
- Significant pain of alternate etiology other than the neuropathic pain state
- Severe pulmonary disease
- Recent myocardial infarction (within the preceding three months)
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 |
|---|---|---|
| Transdermal Fentanyl | Drug | – |
Primary outcome
Change in pain intensity (0-10) and daily activity
3 secondary outcomes
Pain relief (0-100%)
Cognition (digital symbol and grooved peg-board)
Impairment of function (MPI) and affect (BDI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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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.
Srinivasa N Raja, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal Fentanyl in people with Peripheral Neuropathy and Complex Regional Pain Syndromes (CRPS), run by Johns Hopkins University.
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 4 inclusion and 9 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in pain intensity (0-10) and daily activity. 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 24 Aug 2017.