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NCT03090620 · ClinicalTrials.gov registry record · Phase 4
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT03090620: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT03090620 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03090620, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis, decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or benzodiazepines. Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly despite evidence of safety and efficacy. To demonstrate the utility and safety of physostigmine, the investigators propose a randomized clinical trial of physostigmine compared to benzodiazepine for antimuscarinic toxicity.
Primary Outcome
Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.
Interventions
- DRUG Lorazepam
- DRUG Physostigmine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-03-30 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 4 |
What the finished NCT03090620 record still lists
NCT03090620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Lorazepam is the first listed.
NCT03090620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03090620 about?
NCT03090620 is a clinical study titled "Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome". Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis, decreased sweat, decreased bo...
What is the current status of trial NCT03090620?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2017-03-30. Estimated completion is 2020-08-31.
What interventions are being tested in trial NCT03090620?
The interventions under investigation include: Lorazepam (DRUG), Physostigmine (DRUG).
Who is sponsoring clinical trial NCT03090620?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03090620's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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