PainPhase 3NCT00004647
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
A Phase 3 study testing mexiletine in people with Pain and Diabetic Neuropathies, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Pain, Diabetic Neuropathies, Paresthesia
- What is being tested?
- mexiletine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 1993to Feb 1999
- Phase
- Phase 3
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Patients with painful diabetic neuropathy
About this study
OBJECTIVES:
- Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.
The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.
- Conditions
- Pain, Diabetic Neuropathies, Paresthesia
- Being tested
- mexiletine
- Keywords
- diabetic neuropathy, disease-related problem/condition, neurologic and psychiatric disorders, pain, rare disease
- Medical subject headings
- Pain, Diabetic Neuropathies, Paresthesia, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mexiletineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startMar 1993
- Study completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Tennessee
- Investigators
- Tulio Bertorini, Study chair, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004647
- Sponsor's protocol ID
- 199/11702
- Other IDs
- UTENN-4686
- Status last verified
- Mar 1999
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00004647
- Acronym / sponsor ID
- 199/11702
- Conditions
- Pain, Diabetic Neuropathies, Paresthesia
- Keywords
- diabetic neuropathy, disease-related problem/condition, neurologic and psychiatric disorders, pain, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Tennessee
- Study start
- Mar 1993
- Study completion
- Feb 1999
- First posted
- 25 Feb 2000 (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.
OBJECTIVES:
- Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.
The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| mexiletine | Drug | – |
Primary outcome
Not reported in the source record.
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 Jun 2005.
- BackgroundBertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
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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.
Tulio Bertorini study chair
University of Tennessee
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mexiletine in people with Pain and Diabetic Neuropathies, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Jun 2005. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004647, which also lists 1 linked publication.
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 Jun 2005.