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NCT00235469 · ClinicalTrials.gov registry record · Phase 2
A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
A Phase 2 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 496
- Enrollment target
NCT00235469 is a Phase 2 study that has completed, run by UCB Pharma. The registered enrollment target is 496 participants.
The verdict
NCT00235469, a Phase 2 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 496 participants
- Enrollment target
Study Summary
This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.
Interventions
- DRUG SPM 927
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00235469
The ClinicalTrials.gov registry entry for NCT00235469 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Pharma, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SPM 927 is the first listed.
NCT00235469 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00235469 about?
NCT00235469 is a clinical study titled "A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy". This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for th...
What is the current status of trial NCT00235469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 496 participants. The study started on 2004-04. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00235469?
The interventions under investigation include: SPM 927 (DRUG).
Who is sponsoring clinical trial NCT00235469?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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