Trials / Completed
CompletedNCT01128738
GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Including an Open-label Phase to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Axillary Hyperhidrosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK1358820 | Onabotulinum toxin type A |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2010-05-24
- Last updated
- 2015-06-08
- Results posted
- 2012-04-25
Locations
14 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01128738. Inclusion in this directory is not an endorsement.