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NCT04726345 · ClinicalTrials.gov registry record · Phase 2
Effect of Antihistamines on Ureteral Stent-Related Symptoms
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT04726345 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 78 participants.
The verdict
NCT04726345, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Eligible patients will be randomly and divided into two groups in a 1:1 ratio. Group A will receive fexofenadine 180 mg once daily in addition to standard of care treatment. Group B will receive placebo in addition to standard of care treatment. The routine standard of care treatment will consist of oral non-steroidal anti-inflammatory drugs (NSAIDs). The primary outcomes of the study are the Ureteral Stent Symptom Questionnaire (USSQ) urinary symptom score and pain score. Secondary outcomes include (i) number of office phone calls due to urinary symptoms; (ii) duration of analgesic use; (iii) duration and quantity of narcotic use; (iv) number of emergency department visits; (v) drug-related adverse effects; (vi) other domains of the USSQ.
Interventions
- DRUG Placebo
- DRUG Fexofenadine Hcl 180Mg Tab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04726345
The ClinicalTrials.gov registry entry for NCT04726345 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04726345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04726345 about?
NCT04726345 is a clinical study titled "Effect of Antihistamines on Ureteral Stent-Related Symptoms". This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Eligible patients wil...
What is the current status of trial NCT04726345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2021-06-29. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT04726345?
The interventions under investigation include: Placebo (DRUG), Fexofenadine Hcl 180Mg Tab (DRUG).
Who is sponsoring clinical trial NCT04726345?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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