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NCT00001344 · ClinicalTrials.gov registry record · Phase 2
Dextromethorphan Versus Placebo for Neuropathic Pain
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT00001344 is a Phase 2 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 129 participants.
The verdict
NCT00001344, a Phase 2 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to 920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo. Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's disease. The underlying hypothesis, based on studies of painful neuropathies in animal models, is that neuropathic pain is caused largely by sensitization of central nervous system neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and consists of three 9-week treatment periods. Patients who respond to one of the medications will be invited to participate in further controlled studies of the medication followed by up to several years of open-label treatment under continued observation.
Interventions
- DRUG dextromethorphan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 1993-03 |
| Est. Completion | 2001-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001344
The ClinicalTrials.gov registry entry for NCT00001344 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dextromethorphan is the first listed.
NCT00001344 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001344 about?
NCT00001344 is a clinical study titled "Dextromethorphan Versus Placebo for Neuropathic Pain". In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to 920 mg/day (about 8 time...
What is the current status of trial NCT00001344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 1993-03. Estimated completion is 2001-02.
What interventions are being tested in trial NCT00001344?
The interventions under investigation include: dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT00001344?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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