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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

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ClinicalTrials.gov Identifier: NCT00491894
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : July 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Information provided by:
Shionogi Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cerebral Palsy
Neurological Conditions
Mental Retardation
Sialorrhea
Intervention Drug: Oral Glycopyrrolate Liquid
Enrollment 137
Recruitment Details First patient was enrolled on April 03, 2007 and last patient completed on May 30, 2008
Pre-assignment Details After a washout and screening period, and 2-day baseline period, patients were enrolled in a 4-week dose titration period which commenced with the goal of identifying an optimal 3 times daily maintenance dose for each patient. The resulting individualized optimal maintenance dose was to be administered for the remainder of the 24-week study
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Period Title: Overall Study
Started 137
Completed 103
Not Completed 34
Reason Not Completed
Adverse Event             14
Withdrawal by Subject             5
Death             3
Lost to Follow-up             3
Lack of Efficacy             2
Other-Failed to meet any criteria             2
Physician Decision             2
Protocol Violation             2
Other-Intake of prohibited medication             1
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Overall Number of Baseline Participants 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
<=18 years
137
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants
11.0  (4.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
Female
60
  43.8%
Male
77
  56.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
Hispanic or Latino
15
  10.9%
Not Hispanic or Latino
121
  88.3%
Unknown or Not Reported
1
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
American Indian or Alaska Native
1
   0.7%
Asian
4
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
29
  21.2%
White
98
  71.5%
More than one race
0
   0.0%
Unknown or Not Reported
5
   3.6%
1.Primary Outcome
Title Proportion of Responders According to the Modified Teacher’s Drooling Scale (mTDS)
Hide Description The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done by intention to treat method. For purposes of statistical estimation, patients who dropped out due to lack of efficacy had their worst observation carried forward. Patients who dropped out for reasons other than lack of efficacy had their last observation carried forward
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description:
A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: Participants
Responders 68
Non-Responders 62
Missing 7
2.Secondary Outcome
Title Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)
Hide Description Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description:
A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Overall Number of Participants Analyzed 137
Mean (Standard Deviation)
Unit of Measure: VAS score
6.56  (2.34)
3.Secondary Outcome
Title Parent/Caregiver's Assessment of the Extent of Drooling Using VAS
Hide Description Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description:
A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Overall Number of Participants Analyzed 137
Mean (Standard Deviation)
Unit of Measure: VAS score
3.21  (2.20)
4.Secondary Outcome
Title Parent/Caregiver's Global Assessment of Treatment
Hide Description The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’(neutral, disagree, and strongly disagree responses aggregated)
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis for parent/caregiver's Global Assessment was done by intention to treat method
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description:
A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: Participants
Responders 101
Non-Responders 20
Missing 16
5.Secondary Outcome
Title Investigator's Global Assessment of Treatment
Hide Description The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’ (neutral, disagree, and strongly disagree responses aggregated)
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis for investigator's Global Assessment was done by intention to treat method
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description:
A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: Participants
Responders 109
Non-Responders 18
Missing 10
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Chronic Drooling
Hide Arm/Group Description A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
All-Cause Mortality
Patients With Chronic Drooling
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Chronic Drooling
Affected / at Risk (%) # Events
Total   14/137 (10.22%)    
Gastrointestinal disorders   
Impaired gastric emptying  1/137 (0.73%)  1
Gastrointestinal motility disorder  1/137 (0.73%)  1
General disorders   
Multi-organ failure  1/137 (0.73%)  1
Infections and infestations   
Urinary tract infection  1/137 (0.73%)  1
Otitis media  1/137 (0.73%)  1
Esophageal candidiasis  1/137 (0.73%)  1
Cellulitis 1 [1]  1/137 (0.73%)  1
Pneumonia  3/137 (2.19%)  3
Injury, poisoning and procedural complications   
Therapeutic agent toxicity  1/137 (0.73%)  1
Metabolism and nutrition disorders   
Dehydration  1/137 (0.73%)  1
Nervous system disorders   
Nystagmus * 1  1/137 (0.73%)  1
Convulsion * 1  1/137 (0.73%)  1
Hydrocephalus  1/137 (0.73%)  1
Anoxic encephalopathy  1/137 (0.73%)  1
Respiratory, thoracic and mediastinal disorders   
Tonsillar hypertrophy  1/137 (0.73%)  1
Pneumonia aspiration  1/137 (0.73%)  1
Aspiration  1/137 (0.73%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 10.0
[1]
The serious adverse event of cellulitis was not related to the study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Patients With Chronic Drooling
Affected / at Risk (%) # Events
Total   122/137 (89.05%)    
Gastrointestinal disorders   
Constipation  28/137 (20.44%) 
Diarrhea  24/137 (17.52%) 
Vomiting  24/137 (17.52%) 
Dry mouth  15/137 (10.95%) 
Lip dry  5/137 (3.65%) 
General disorders   
Pyrexia  20/137 (14.60%) 
Irritability  8/137 (5.84%) 
Infections and infestations   
Otitis media  11/137 (8.03%) 
Urinary tract infection  10/137 (7.30%) 
Upper respiratory tract infection  11/137 (8.03%) 
Influenza  7/137 (5.11%) 
Pharyngitis streptococcal  7/137 (5.11%) 
Sinusitis  6/137 (4.38%) 
Gastroenteritis viral  6/137 (4.38%) 
Nasopharyngitis  5/137 (3.65%) 
Viral upper respiratory tract infection  5/137 (3.65%) 
Injury, poisoning and procedural complications   
Feeding tube complication  5/137 (3.65%) 
Procedural pain  5/137 (3.65%) 
Investigations   
Urine output decreased  5/137 (3.65%) 
Nervous system disorders   
Convulsion  10/137 (7.30%) 
Somnolence  7/137 (5.11%) 
Headache  6/137 (4.38%) 
Psychiatric disorders   
Restlessness  5/137 (3.65%) 
Renal and urinary disorders   
Dysuria  9/137 (6.57%) 
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  15/137 (10.95%) 
Epistaxis  7/137 (5.11%) 
Upper respiratory tract congestion  6/137 (4.38%) 
Skin and subcutaneous tissue disorders   
Rash  11/137 (8.03%) 
Vascular disorders   
Flushing  15/137 (10.95%) 
1
Term from vocabulary, MedDRA Version 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
Results Point of Contact
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi USA
Phone: 800-849-9707 ext 1454
Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00491894     History of Changes
Obsolete Identifiers: NCT00425087
Other Study ID Numbers: Sc-GLYCO-06-01
First Submitted: June 22, 2007
First Posted: June 26, 2007
Results First Submitted: August 2, 2010
Results First Posted: July 9, 2012
Last Update Posted: July 9, 2012