Treatment of Hyperhidrosis With Oxybutynin

Hyperhidrosis Clinical Trial

— H²O  

Official title:

Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855256
• Other study ID #: RB 12.035 H²O
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2013
• Last updated: July 7, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : ANSM - Agence Nationale de Sécutité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• Patient affiliated to social security or beneficiary of such a regime

• Patient able to consent

• Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.

Exclusion Criteria:

• Age less than 18 years

• Patient who can't be followed

• Patient participating in another clinical trial

• Pregnant

• Woman breastfeeding

• Hypersensitivity to oxybutynin or any of the excipients

• Risk of urinary retention related disorders uretroprostatiques

• Intestinal obstruction

• Toxic megacolon

• Intestinal atony

• Severe Ulcerative Colitis

• Myasthenia

• Closure glaucoma the anterior chamber angle or slightly deep

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• Oxybutynin
Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
• Placebo
Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.

Locations

Country	Name	City	State
France	Hospital, Brest	Brest
France	CHG Landerneau	Landerneau
France	CHG de Morlaix	Morlaix
France	Dermatologist'S Office	Quimper

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effectiveness of oxybutynin in hyperhidrosis	Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )	6 weeks	Yes
Secondary	Safety evaluation of treatment in this indication	Number of Participants with Adverse Events will be followed.	6 weeks	Yes