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NCT03050827 · ClinicalTrials.gov registry record · Phase 3
Muscarinic Receptor Antagonists as a Therapy for Diabetic Neuropathy
A Phase 3 study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT03050827 is a Phase 3 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 51 participants.
The verdict
NCT03050827, a Phase 3 study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
Investigators propose a placebo controlled, double blinded study to examine efficacy of topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2 diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated efficacy of topiramate in reversing IENF loss within 18 weeks in our prior study. Subjects will also undergo quantitative sensory testing (QST) and assays of laser Doppler skin blood flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life (Norfolk QOL-DN), along with standard measures of physiology and fasting blood chemistry. Subjects with IENF loss of between 20-75% of normative values and thus amenable to therapy-induced recovery, will be randomized into placebo (N=30) or active drug (N=30) arms and instructed in how to apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2 region of skin adjacent to the initial biopsy site, as per the manufacturers instructions (http://www.gelnique.com/gel3/). Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance. After 20 weeks, subjects will return for a second series of measurements and 3 mm skin biopsy from the treated region of skin.
Interventions
- DRUG Placebo
- DRUG 3% oxybutynin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-05-01 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03050827
The ClinicalTrials.gov registry entry for NCT03050827 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Virginia Medical School, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03050827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03050827 about?
NCT03050827 is a clinical study titled "Muscarinic Receptor Antagonists as a Therapy for Diabetic Neuropathy". Investigators propose a placebo controlled, double blinded study to examine efficacy of topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2 diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated efficacy of topiramate i...
What is the current status of trial NCT03050827?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2014-05-01. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT03050827?
The interventions under investigation include: Placebo (DRUG), 3% oxybutynin (DRUG).
Who is sponsoring clinical trial NCT03050827?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
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