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Last Updated: July 16, 2020

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CLINICAL TRIALS PROFILE FOR GLYCOPYRROLATE

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505(b)(2) Clinical Trials for Glycopyrrolate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT03915561 Effect of Intravenous Dynastat on Postoperative Sore Throat Recruiting Buddhist Tzu Chi General Hospital Phase 2 2019-03-01 A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Both nonpharmacological and pharmacological measures have been attempted to alleviate the incidence and severity of POST with variable success. Airway inflammation may be important in the pathogenesis of these symptoms in intubated participants but however, there was still no study to investigate the effect of cyclooxygenase-2 (COX-2) for the prevention of POST. So, the investigators' study will be the first one to investigate if perioperatively intravenous (IV) Dynastat injection can be used as a new indication for POST prevention.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Glycopyrrolate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00315536 Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children Completed University Hospital, Ghent Phase 2 2006-05-01 Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulating volume, some of the subjects will receive additional fluid.This will be evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.
NCT00491894 Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions Completed Shionogi Phase 3 2007-03-01 This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.
NCT00558285 Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Completed Novartis Phase 2 2007-11-01 An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glycopyrrolate

Condition Name

Condition Name for Glycopyrrolate
Intervention Trials
Chronic Obstructive Pulmonary Disease (COPD) 8
Chronic Obstructive Pulmonary Disease 8
COPD 8
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Condition MeSH

Condition MeSH for Glycopyrrolate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 22
Lung Diseases 21
Lung Diseases, Obstructive 20
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Clinical Trial Locations for Glycopyrrolate

Trials by Country

Trials by Country for Glycopyrrolate
Location Trials
United States 210
Japan 17
India 13
Korea, Republic of 11
Canada 8
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Trials by US State

Trials by US State for Glycopyrrolate
Location Trials
New York 13
Oregon 10
Texas 10
Florida 9
Illinois 9
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Clinical Trial Progress for Glycopyrrolate

Clinical Trial Phase

Clinical Trial Phase for Glycopyrrolate
Clinical Trial Phase Trials
Phase 4 48
Phase 3 18
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Glycopyrrolate
Clinical Trial Phase Trials
Completed 59
Recruiting 29
Not yet recruiting 27
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Clinical Trial Sponsors for Glycopyrrolate

Sponsor Name

Sponsor Name for Glycopyrrolate
Sponsor Trials
Chiesi Farmaceutici S.p.A. 11
Sunovion Respiratory Development Inc. 9
Merck Sharp & Dohme Corp. 8
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Sponsor Type

Sponsor Type for Glycopyrrolate
Sponsor Trials
Other 104
Industry 39
U.S. Fed 6
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