Trial · 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
NCT00491894, Phase 3, Completed, Shionogi; results first posted 2012-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT00491894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00491894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00491894
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 137 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Interventions
- Oral Glycopyrrolate Liquid
- First posted
- 2007-06-26
- Last updated
- 2012-07-09
- Results first posted
- 2012-07-09
- Limitations and caveats
- There were no limitations of the trial
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) | 6 months | 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 |
| Secondary | Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS) | Baseline | 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. |
| Secondary | Parent/Caregiver's Assessment of the Extent of Drooling Using VAS | Week 24 | 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. |
| Secondary | Parent/Caregiver's Global Assessment of Treatment | Week 24 | 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) |
| Secondary | Investigator's Global Assessment of Treatment | Week 24 | 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) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) | 6 months | 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 | Participants | NUMBER |
| SECONDARY | Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS) | Baseline | VAS score | MEAN | |
| SECONDARY | Parent/Caregiver's Assessment of the Extent of Drooling Using VAS | Week 24 | VAS score | MEAN | |
| SECONDARY | Parent/Caregiver's Global Assessment of Treatment | Week 24 | The analysis for parent/caregiver's Global Assessment was done by intention to treat method | Participants | NUMBER |
| SECONDARY | Investigator's Global Assessment of Treatment | Week 24 | The analysis for investigator's Global Assessment was done by intention to treat method | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) | Patients With Chronic Drooling | Responders | 68 | Participants | |
| Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) | Patients With Chronic Drooling | Non-Responders | 62 | Participants | |
| Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) | Patients With Chronic Drooling | Missing | 7 | Participants | |
| Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS) | Patients With Chronic Drooling | 6.56 | Standard Deviation 2.34 | VAS score | |
| Parent/Caregiver's Assessment of the Extent of Drooling Using VAS | Patients With Chronic Drooling | 3.21 | Standard Deviation 2.20 | VAS score | |
| Parent/Caregiver's Global Assessment of Treatment | Patients With Chronic Drooling | Responders | 101 | Participants | |
| Parent/Caregiver's Global Assessment of Treatment | Patients With Chronic Drooling | Non-Responders | 20 | Participants | |
| Parent/Caregiver's Global Assessment of Treatment | Patients With Chronic Drooling | Missing | 16 | Participants | |
| Investigator's Global Assessment of Treatment | Patients With Chronic Drooling | Responders | 109 | Participants | |
| Investigator's Global Assessment of Treatment | Patients With Chronic Drooling | Non-Responders | 18 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With Chronic Drooling | 137 | |
| Overall Study | COMPLETED | Patients With Chronic Drooling | 103 | |
| Overall Study | NOT COMPLETED | Patients With Chronic Drooling | 34 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Patients With Chronic Drooling | 28 | 137 | |
| other | Diarrhea | Gastrointestinal disorders | Patients With Chronic Drooling | 24 | 137 | |
| other | Vomiting | Gastrointestinal disorders | Patients With Chronic Drooling | 24 | 137 | |
| other | Dry mouth | Gastrointestinal disorders | Patients With Chronic Drooling | 15 | 137 | |
| other | Lip dry | Gastrointestinal disorders | Patients With Chronic Drooling | 5 | 137 | |
| other | Otitis media | Infections and infestations | Patients With Chronic Drooling | 11 | 137 | |
| other | Urinary tract infection | Infections and infestations | Patients With Chronic Drooling | 10 | 137 | |
| other | Upper respiratory tract infection | Infections and infestations | Patients With Chronic Drooling | 11 | 137 | |
| other | Influenza | Infections and infestations | Patients With Chronic Drooling | 7 | 137 | |
| other | Pharyngitis streptococcal | Infections and infestations | Patients With Chronic Drooling | 7 | 137 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With Chronic Drooling | ||
| Total, other adverse events | Patients With Chronic Drooling | 122 | 137 |
| Total, serious adverse events | Patients With Chronic Drooling | 14 | 137 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22298950 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00491894
GET https://conductscience.org/api/trials/v1/NCT00491894/events?page=2