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NCT03569098 · ClinicalTrials.gov registry record · Phase 2
Dysport in Hallux Abducto Valgus (HAV) Phase IIa
A Phase 2 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 2
- Development phase
- 186
- Enrollment target
NCT03569098: Completed Phase 2 study, sponsored by Ipsen.
NCT03569098 is a Phase 2 study that has completed, run by Ipsen. The registered enrollment target is 186 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03569098, a Phase 2 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 186 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.
Primary Outcome
The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an electronic diary (eDiary) for 7 consecutive days prior
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2020-05-22 |
| Phase | Phase 2 |
What the finished NCT03569098 record still lists
NCT03569098 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03569098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03569098 about?
NCT03569098 is a clinical study titled "Dysport in Hallux Abducto Valgus (HAV) Phase IIa". The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.
What is the current status of trial NCT03569098?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2018-06-19. Estimated completion is 2020-05-22.
What interventions are being tested in trial NCT03569098?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT03569098?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03569098's enrollment target sits among peer trials
186 357th of 2000 higher than 1,644 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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