A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 15
- 主要终点
- Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
研究概览
简要总结
The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.
详细描述
This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.
Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).
Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.
PK blood samples will be taken study subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older.
- •Primary, axillary hyperhidrosis of at least 6 months duration.
- •Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
- •For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
- •Male or non-pregnant, non-lactating females.
排除标准
- •Current pregnancy or lactation.
- •Prior surgical procedure for hyperhidrosis.
- •Any prior axillary treatment with an anti-hyperhidrosis medical device
- •Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
- •Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day
- •Subjects with clinically significant abnormalities in laboratory values.
- •Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
- •Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day
- •Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day
- •Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
- •Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day
- •Any previous IV or oral treatment with the study drug.
- •Prior treatment with the topical study drug in a previous trial.
- •Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
- •Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis
- •Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
- •Known history of Sjögren's syndrome or Sicca syndrome.
- •History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
- •Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
- •Abnormal findings on screening ECG deemed clinically significant by the Investigator.
- •History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia
研究组 & 干预措施
Dose 1 of glycopyrrolate, 2.0% QD
glycopyrrolate Topical Wipes
干预措施: Dose 1 of glycopyrrolate, 2.0% QD (Drug)
Dose 2 of glycopyrrolate, 3.0% QD
glycopyrrolate Topical Wipes
干预措施: Dose 2 of glycopyrrolate, 3.0% QD (Drug)
Dose 1 of glycopyrronium, 2.5% QD
glycopyrronium Topical Wipes
干预措施: Dose 1 of glycopyrronium, 2.5% QD (Drug)
Dose 2 of glycopyrronium, 3.75% QD
glycopyrronium Topical Wipes
干预措施: Dose 2 of glycopyrronium, 3.75% QD (Drug)
Vehicle
Vehicle Topical Wipes
干预措施: Vehicle (Other)
结局指标
主要结局
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
时间窗: Baseline - Week 4
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
时间窗: Baseline - Week 6
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
时间窗: Baseline - Week 6
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
时间窗: Baseline - Week 4/ET
HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (Best), 2, 3, 4 (Worst)
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
时间窗: Baseline - Week 4
Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
次要结局
- Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4(Baseline - Week 4)
- Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6(Baseline - Week 6)