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NCT02673619 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects
A Phase 2 study of Hyperhidrosis, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 6
- Study locations
NCT02673619: Completed Phase 2 study of Hyperhidrosis, sponsored by Stiefel, a GSK Company.
NCT02673619 is a Phase 2 study of Hyperhidrosis that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 58 participants, below the 92-participant average among 8 other Hyperhidrosis trials with a reported enrollment target (37% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02673619, a Phase 2 study of Hyperhidrosis, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 6
- Study locations
Study Summary
Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is anticipated that topical administration of UMEC will block stimulation of muscarinic receptors, thereby reducing the overproduction of sweat in subjects who suffer from hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and tolerability of topically applied UMEC following once daily topical administration, for 28 days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also investigate if topically applied UMEC, at the highest possible concentration, will decrease palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or below that observed with inhaled administration. This is a double blind (Sponsor unblind), repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55 subjects.
Primary Outcome
A response rate is defined as percentage of participants who achieved at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29. Baseline was latest assessment prior to first dosing. A response rate of greater than 50 percent was considered to be clinically meaningful (greater than 50 percent of participants achieving at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29). The posterior probability that response rate in sweat production i
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Umeclidinium
Study Locations (6)
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - College Station
- GSK Investigational Site - Houston
Nebraska
- GSK Investigational Site - Omaha
North Carolina
- GSK Investigational Site - Raleigh
Quebec
- GSK Investigational Site - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2016-12-08 |
| Phase | Phase 2 |
What the finished NCT02673619 record still lists
NCT02673619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 92-participant average among 8 other Hyperhidrosis trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Hyperhidrosis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT02673619 lists 6 locations in 4 states (Texas, Nebraska, North Carolina).
Frequently Asked Questions
What is clinical trial NCT02673619 about?
NCT02673619 is a clinical study titled "A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects". Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is anticipated that topical administration of UMEC will block stimulation of muscarinic receptors, thereby reducing the overproduction of sweat in subjects who suffer from hyperhidrosis. This study will assess th...
What is the current status of trial NCT02673619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2016-03-07. Estimated completion is 2016-12-08.
What conditions does trial NCT02673619 study?
This clinical trial studies the following conditions: Hyperhidrosis.
What interventions are being tested in trial NCT02673619?
The interventions under investigation include: Vehicle (DRUG), Umeclidinium (DRUG).
Who is sponsoring clinical trial NCT02673619?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02673619 being conducted?
This trial has 6 study locations across Nebraska, North Carolina, Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hyperhidrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02673619's enrollment target sits among peer trials
58 6th of 8 higher than 3 of 8 other Hyperhidrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperhidrosis 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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