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NCT01309802 · ClinicalTrials.gov registry record · Phase 2
A Two-Part Study of BOTOX® Therapy for Ischemic Digits
A Phase 2 study of Raynaud's Disease, sponsored by Southern Illinois University.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01309802 is a Phase 2 study of Raynaud's Disease that has completed, run by Southern Illinois University. The registered enrollment target is 48 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01309802, a Phase 2 study of Raynaud's Disease, has completed, sponsored by Southern Illinois University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is extremely challenging. Published reports and our previous work support our hypothesis that symptomatic patients experience relief of pain and healing of ulcerations with minimal adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's phenomenon. The proposed study is the first clinical trial and prospective study designed to document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection relieves pain associated with Raynaud's disease for longer than 28 days, improving patients' quality of life. Through this study we intend to further determine the effect of injected Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing the patients for whom this treatment is most effective.
Conditions Studied
Interventions
- DRUG onabotulinum toxin type-A
Study Locations (1)
Illinois
- Southern Illinois University School of Medicine - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-05 |
| Est. Completion | 2016-07-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01309802
The ClinicalTrials.gov registry entry for NCT01309802 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern Illinois University, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Raynaud's Disease appearing as the primary indexed condition, and to 1 intervention - of which onabotulinum toxin type-A is the first listed.
NCT01309802 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01309802 about?
NCT01309802 is a clinical study titled "A Two-Part Study of BOTOX® Therapy for Ischemic Digits". Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is extremely challenging. Published reports and our previous work support our hypothesis that symptomatic patients experience relief of pain and healing of ulcerations with minimal adverse effects when treated with bot...
What is the current status of trial NCT01309802?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-05. Estimated completion is 2016-07-13.
What conditions does trial NCT01309802 study?
This clinical trial studies the following conditions: Raynaud's Disease.
What interventions are being tested in trial NCT01309802?
The interventions under investigation include: onabotulinum toxin type-A (DRUG).
Who is sponsoring clinical trial NCT01309802?
This trial is sponsored by Southern Illinois University, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01309802 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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