- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181246
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
August 23, 2017 updated by: Johns Hopkins University
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
53
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Dementia
- Encephalopathy
- Those with life expectancy of less than six months and HIV seropositivity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in pain intensity (0-10) and daily activity
|
Secondary Outcome Measures
Outcome Measure |
---|
Pain relief (0-100%)
|
Cognition (digital symbol and grooved peg-board)
|
Impairment of function (MPI) and affect (BDI)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Srinivasa N Raja, MD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 23, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Autonomic Nervous System Diseases
- Peripheral Nervous System Diseases
- Complex Regional Pain Syndromes
- Reflex Sympathetic Dystrophy
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- 20021288
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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