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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: Completed Phase 2 study of Raynaud's Disease, sponsored by Southern Illinois University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjective pain scales \[visual analogue scale (VAS) and faces pain assessment\]. Subjects reporting total number of pain free days within the time period of 0-28 days.
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 |
What the finished NCT01309802 record still lists
NCT01309802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01309802's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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