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NCT03359473 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study of Cachexia, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 11
- Study locations
NCT03359473 is a Phase 2 study of Cachexia that has completed, run by GlaxoSmithKline. The registered enrollment target is 97 participants, below the 195-participant average among 13 other Cachexia trials with a reported enrollment target (50% lower). The trial reports 11 study locations across 10 states.
The verdict
NCT03359473, a Phase 2 study of Cachexia, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 11
- Study locations
Study Summary
Impaired physical function and muscle dysfunction are a major consequence of COPD, which may be associated with increased mortality, poor quality of life and increased health care use. This is a randomized, placebo-controlled, double-blind, parallel group study to evaluate the safety and tolerability of GSK2881078, an SARM over 13 weeks of dosing in older male subjects and post-menopausal female subjects with COPD and muscle weakness. This study will also assess the effect of GSK2881078 on physical strength and function after 13 weeks of treatment. Approximately 100 subjects with COPD and muscle weakness will be randomized into two cohorts of 50 male subjects and 50 female subjects. Within each cohort, subjects will be randomized to receive GSK2881078 or placebo in a ratio of 1:1. All subjects will participate in a standardized home exercise program, which will consist of daily walking, along with several resistance or weight-bearing exercises, such as bicep curls, upright rows, step ups and a sit-to-stand maneuver. The study will consist of a screening/Baseline period of up to 30 days, a 13-week treatment period and a post-treatment follow-up period of 6 weeks.
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG GSK2881078
Study Locations (11)
Other
- GSK Investigational Site - London
- GSK Investigational Site - London, Greater London
California
- GSK Investigational Site - Torrance
Florida
- GSK Investigational Site - Jacksonville
North Carolina
- GSK Investigational Site - High Point
Pennsylvania
- GSK Investigational Site - Philadelphia
South Carolina
- GSK Investigational Site - Spartanburg
Hesse
- GSK Investigational Site - Frankfurt am Main
Schleswig-Holstein
- GSK Investigational Site - Großhansdorf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2019-11-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03359473
The ClinicalTrials.gov registry entry for NCT03359473 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 13 other Cachexia trials with a reported enrollment target (50% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cachexia appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.
NCT03359473 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03359473 about?
NCT03359473 is a clinical study titled "Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)". Impaired physical function and muscle dysfunction are a major consequence of COPD, which may be associated with increased mortality, poor quality of life and increased health care use. This is a randomized, placebo-controlled, double-blind, parallel group study to evaluate the safety and tolerabilit...
What is the current status of trial NCT03359473?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2018-02-28. Estimated completion is 2019-11-19.
What conditions does trial NCT03359473 study?
This clinical trial studies the following conditions: Cachexia.
What interventions are being tested in trial NCT03359473?
The interventions under investigation include: Matching Placebo (DRUG), GSK2881078 (DRUG).
Who is sponsoring clinical trial NCT03359473?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03359473 being conducted?
This trial has 11 study locations across California, Florida, North Carolina, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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