Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00491894 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
NCT00491894 is a Phase 3 study that has completed, run by Shionogi. The registered enrollment target is 137 participants.
The verdict
NCT00491894, a Phase 3 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Oral Glycopyrrolate Liquid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00491894
The ClinicalTrials.gov registry entry for NCT00491894 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral Glycopyrrolate Liquid is the first listed.
NCT00491894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00491894 about?
NCT00491894 is a clinical study titled "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". 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 time...
What is the current status of trial NCT00491894?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2007-03. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00491894?
The interventions under investigation include: Oral Glycopyrrolate Liquid (DRUG).
Who is sponsoring clinical trial NCT00491894?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.