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NCT01671800 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating
A Phase 1 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01671800: Completed Phase 1 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT01671800 is a Phase 1 study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01671800, a Phase 1 study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objective of this study is to determine if Myobloc significantly decreases prosthesis-associated symptomatic sweating in amputees when compared to a saline solution placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a total enrollment of 32 amputee subjects.
Primary Outcome
The amount of sweating will be assessed via gravimetry, which is an accepted method for determining sweating in a particular area. This method involves covering the area of the residual limb in question with filter paper for five minutes. After five minutes, the filter paper is removed and weighed. The weight of the dry filter paper is subtracted to give the approximate weight of the sweat produced. This study will use the total weight of sweat produced as a method of objectively quantifying the
Interventions
- DRUG Placebo
- DRUG Botulinum Type B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01671800 record still lists
NCT01671800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01671800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01671800 about?
NCT01671800 is a clinical study titled "Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating". The objective of this study is to determine if Myobloc significantly decreases prosthesis-associated symptomatic sweating in amputees when compared to a saline solution placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a total enrollment of 32 amputee subjects.
What is the current status of trial NCT01671800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01671800?
The interventions under investigation include: Placebo (DRUG), Botulinum Type B (DRUG).
Who is sponsoring clinical trial NCT01671800?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01671800's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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