Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 9 - Any |
Updated: | 10/26/2018 |
Start Date: | August 2015 |
End Date: | December 2016 |
An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up
to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04
or DRM04-HH05 studies.
to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04
or DRM04-HH05 studies.
Safety will be assessed through adverse events, blood and urine laboratory tests, physical
examination, pulse and blood pressure. Local skin reactions will be assessed including
burning/stinging, pruritus, edema, erythema, dryness and scaling.
examination, pulse and blood pressure. Local skin reactions will be assessed including
burning/stinging, pruritus, edema, erythema, dryness and scaling.
Inclusion Criteria:
- Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80%
treatment compliance
- Male or females
Exclusion Criteria:
- Subject has a clinically significant abnormality on physical exam, vital signs or ECG
at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further
treatment with glycopyrronium contraindicated
- Male with a history of urinary retention requiring catheterization due to prostatic
hypertrophy or severe obstructive symptoms of prostatic hypertrophy
- Any other condition which, in the judgement of the Investigator, would put the subject
at unacceptable risk for participation in the study
We found this trial at
41
sites
Omaha, Nebraska 68134
Principal Investigator: Brandon Essink, MD
Phone: 402-933-6500
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Albuquerque, New Mexico 87106
Principal Investigator: Eduardo Tschen
Phone: 505-247-4220
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Berlin, 10117
Principal Investigator: Alexander Nast
Phone: +49 (0)3045 0518313
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Boca Raton, Florida 33486
Principal Investigator: Marta Rendon, MD
Phone: 407-786-9715
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Boynton Beach, Florida 33437
Principal Investigator: Joshua Berlin, MD
Phone: 561-739-5252
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Carmel, Indiana
Principal Investigator: Stephen Shideler, MD
Phone: 317-819-1268
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Charleston, Pennsylvania 29414
Principal Investigator: Todd Schlesinger, MD, FAAD
Phone: 843-518-6610
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Charlottesville, Virginia 22911
Principal Investigator: Anna Magee, MD
Phone: 434-984-2400
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College Station, Texas 77845
Principal Investigator: Terry Jones, MD
Phone: 979-774-5933
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Dallas, Texas 75231
Principal Investigator: Jennifer Cather, MD
Phone: 519-576-0768
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Denver, Colorado 80210
Principal Investigator: James Swinehart, MD
Phone: 303-744-7000
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Edina, Minnesota 55424
Principal Investigator: Brian Zelickson, MD
Phone: 952-746-1017
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Encinitas, California 92024
Principal Investigator: Stacy Smith, MD
Phone: 760-203-3839
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Goodlettsville, Tennessee 37072
Principal Investigator: Keith Loven, MD, CPI
Phone: 615-859-0900
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Houston, Texas 77030
Principal Investigator: Adelaide Hebert, MD
Phone: 713-500-8266
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Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
Phone: 310-337-7171
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Miami, Florida 33144
Principal Investigator: Javier Alonso-Llamazares, MD
Phone: 305-225-0400
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Mobile, Alabama 36608
Principal Investigator: Belin Bodie, MD
Phone: 251-414-1984
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Nashville, Tennessee 37203
Principal Investigator: Stephan Sharp, MD
Phone: 615-329-0197
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New York, New York 10022
Principal Investigator: Eric Schweiger, MD
Phone: 305-933-6716
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Norfolk, Virginia 23507
Principal Investigator: David Pariser, MD
Phone: 757-625-0151
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North Miami Beach, Florida 33162
Principal Investigator: Tory Sullivan, MD
Phone: 321-276-4158
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Pflugerville, Texas 78660
Principal Investigator: Edward Lain, MD, MBA
Phone: 512-279-2545
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Plainfield, Indiana 46168
Principal Investigator: Scott Guenthner, MD
Phone: 317-837-6082
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5425 West Spring Creek Parkway
Plano, Texas 75024
Plano, Texas 75024
Principal Investigator: Seemal Desai, MD, FAAD
Phone: 972-354-1520
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Portland, Oregon 97210
Principal Investigator: Phoebe Rich, MD
Phone: 503-226-3376
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Rochester, New York 14623
Principal Investigator: John Tu, MD
Phone: 585-697-1818
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Rockville, Maryland 20850
Principal Investigator: Lawrence Green, MD
Phone: 301-610-0663
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Rogers, Arkansas 72758
Principal Investigator: Cheryl Hull, MD
Phone: 479-876-8205
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Salt Lake City, Utah 84124
Principal Investigator: Leonard Swinyer, MD
Phone: 801-269-0135
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San Antonio, Texas 78218
Principal Investigator: Emily Becker, MD
Phone: 210-829-5180
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San Diego, California 92123
Principal Investigator: Neal Bhatia, MD
Phone: 858-571-6800
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Santa Monica, California 90404
Principal Investigator: Paul Yamauchi, MD, PhD
Phone: 310-828-8887
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Seattle, Washington 98101
Principal Investigator: Peter Jenkin, MD
Phone: 206-315-0371
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Spokane, Washington 99204
Principal Investigator: William Werschler, MD
Phone: 509-343-3710
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West Jordan, Utah 84088
Principal Investigator: Douglass Forsha, MD
Phone: 801-316-0266
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West Palm Beach, Florida 33401
Principal Investigator: Kenneth Beer, MD
Phone: 561-655-9055
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Wichita, Kansas 67226
Principal Investigator: Jeffrey Davis, MD
Phone: 316-425-6333
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