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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 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.

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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.

Conditions Studied

Hyperhidrosis

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

FieldValue
Enrollment Target 58 participants
Start Date 2016-03-07
Est. Completion 2016-12-08
Phase Phase 2

Sponsor

Stiefel, a GSK Company

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02673619

The ClinicalTrials.gov registry entry for NCT02673619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 92-participant average among 8 other Hyperhidrosis trials with a reported enrollment target (37% lower). The listed sponsor is Stiefel, a GSK Company, which has 37 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.